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1. Early inflammation as a footprint of increased mortality risk in infants living with HIV from three African countries

Author

Morrocchi, Elena, Pascucci, Giuseppe R., Cotugno, Nicola, Pighi, Chiara, Dominguez-Rodriguez, Sara, Petrara, Maria Raffaella, Tagarro, Alfredo, Kuhn, Louise, Cotton, Mark F., Otwombe, Kennedy, Lain, Maria G., Vaz, Paula, Barnabas, Shaun L., Spyer, Moira J., Lopez, Elisa, Fernández-Luis, Sheila, Nhampossa, Tacilta, Maiga, Almoustapha I., Dolo, Oumar, De Rossi, Anita, Rojo, Pablo, Giaquinto, Carlo, Lichterfeld, Mathias, Violari, Avy, Smit, Theresa, Behuhuma, Osee, Klein, Nigel, De Armas, Lesley, Pahwa, Savita, Rossi, Paolo, and Palma, Paolo

Published
2024
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2. Lung function tracking in children with perinatally acquired HIV following early antiretroviral therapy initiation

Author

Gie, André, Davies, Claire, Vaida, Florin, Morrison, Julie, Maree, David, Otwombe, Kennedy, Browne, Sara H, van der Zalm, Marieke M, Cotton, Mark F, Innes, Steve, and Goussard, Pierre

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Prevention, Clinical Research, Pediatric, Infectious Diseases, Lung, Pediatric Research Initiative, HIV/AIDS, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Respiratory, Good Health and Well Being, Female, Pregnancy, Humans, Child, HIV Infections, Vital Capacity, Lung Volume Measurements, Pulmonary Disease, Chronic Obstructive, Forced Expiratory Volume, Spirometry, Paediatric Lung Disaese, Lung Physiology, Respiratory Measurement, Systemic disease and lungs, Clinical Sciences, Respiratory System, Cardiovascular medicine and haematology, Clinical sciences
Abstract

IntroductionLung disease remains a frequent complication in children with perinatal HIV infection (CHIV) and exposure without infection (CHEU), resulting in diminished lung function. In CHIV, early antiretroviral therapy (ART) initiation improves survival and extrapulmonary outcomes. However, it is unknown if there is benefit to lung function.MethodsCohorts of CHIV (ART initiated at median 4.0 months), CHEU and HIV-unexposed children (CHU) prospectively performed pulmonary function testing (PFT) consisting of spirometry, plethysmography and diffusing capacity from 2013 to 2020. We determined lung function trajectories for PFT outcomes comparing CHIV to CHU and CHEU to CHU, using linear mixed effects models with multiple imputation. Potential confounders included sex, age, height, weight, body mass index z-score, urine cotinine and Tanner stage.Results328 participants (122 CHIV, 126 CHEU, 80 CHU) performed PFT (ages 6.6-15.6 years). Spirometry (forced expiratory volume in 1 s, FEV1, forced vital capacity (FVC), FEV1/FVC) outcomes were similar between groups. In plethysmography, the mean residual volume (RV) z-score was 17% greater in CHIV than CHU (95% CI 1% to 33%, p=0.042). There was no difference in total lung capacity (TLC) or RV/TLC z-scores between groups. Diffusing capacity for carbon monoxide was similar in all groups, while alveolar volume (VA) differed between HIV groups by sex.ConclusionOur study indicates that early ART initiation can mitigate the loss of lung function in CHIV with lasting benefit through childhood; however, there remains concern of small airway disease. CHEU does not appear to disrupt childhood lung function trajectory.

Published
2023

3. Pharmacokinetics and safety of first-line tuberculosis drugs rifampin, isoniazid, ethambutol, and pyrazinamide during pregnancy and postpartum: results from IMPAACT P1026s

Author

Van Schalkwyk, Marije, Bekker, Adrie, Decloedt, Eric, Wang, Jiajia, Theron, Gerhard B, Cotton, Mark F, Eke, Ahizechukwu C, Cressey, Tim R, Shapiro, David E, Bacon, Kira, Knowles, Kevin, George, Kathleen, Browning, Renee, Chakhtoura, Nahida, Rungruengthanakit, Kittipong, Wiesner, Lubbe, Capparelli, Edmund V, Stek, Alice M, Mirochnick, Mark, Best, Brookie M, and Team, on behalf of the IMPAACT P1026s Protocol

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Research, Tuberculosis, HIV/AIDS, Rare Diseases, Infectious Diseases, Prevention, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, IMPAACT P1026s Protocol Team, drug-susceptible tuberculosis, ethambutol, isoniazid, pharmacokinetics, pregnancy, pyrazinamide, rifampin, Microbiology, Medical Microbiology, Pharmacology and Pharmaceutical Sciences, Medical microbiology, Pharmacology and pharmaceutical sciences
Abstract

Physiological changes during pregnancy may alter the pharmacokinetics (PK) of antituberculosis drugs. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1026s was a multicenter, phase IV, observational, prospective PK and safety study of antiretroviral and antituberculosis drugs administered as part of clinical care in pregnant persons living with and without HIV. We assessed the effects of pregnancy on rifampin, isoniazid, ethambutol, and pyrazinamide PK in pregnant and postpartum (PP) persons without HIV treated for drug-susceptible tuberculosis disease. Daily antituberculosis treatment was prescribed following World Health Organization-recommended weight-band dosing guidelines. Steady-state 12-hour PK profiles of rifampin, isoniazid, ethambutol, and pyrazinamide were performed during second trimester (2T), third trimester (3T), and 2-8 of weeks PP. PK parameters were characterized using noncompartmental analysis, and comparisons were made using geometric mean ratios (GMRs) with 90% confidence intervals (CI). Twenty-seven participants were included: 11 African, 9 Asian, 3 Hispanic, and 4 mixed descent. PK data were available for 17, 21, and 14 participants in 2T, 3T, and PP, respectively. Rifampin and pyrazinamide AUC0-24 and C max in pregnancy were comparable to PP with the GMR between 0.80 and 1.25. Compared to PP, isoniazid AUC0-24 was 25% lower and C max was 23% lower in 3T. Ethambutol AUC0-24 was 39% lower in 3T but limited by a low PP sample size. In summary, isoniazid and ethambutol concentrations were lower during pregnancy compared to PP concentrations, while rifampin and pyrazinamide concentrations were similar. However, the median AUC0-24 for rifampin, isoniazid, and pyrazinamide met the therapeutic targets. The clinical impact of lower isoniazid and ethambutol exposure during pregnancy needs to be determined.

Published
2023

5. Pulse wave velocity in early-treated children living with perinatal HIV infection is similar to uninfected children

Author

Davies, Claire, Vaida, Florin, Otwombe, Kennedy, Cotton, Mark F, Browne, Sara H, and Innes, Steve

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Research, Prevention, Infectious Diseases, Pediatric, Pediatric AIDS, Heart Disease, Cardiovascular, Mental Health, Sexually Transmitted Infections, HIV/AIDS, Women's Health, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Pregnancy, Female, Humans, Child, Child, Preschool, HIV Infections, Pulse Wave Analysis, Cardiovascular Diseases, Anti-Retroviral Agents, Cognition, Vascular Stiffness, antiretroviral therapy, cardiovascular risk, children, HIV, metabolic syndrome, pulse wave velocity, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology, Biomedical and clinical sciences, Health sciences
Abstract

IntroductionHIV is associated with accelerated cardiovascular disease, due to HIV-associated metabolic abnormalities, antiretroviral therapy (ART), and HIV itself. Carotid-femoral pulse wave velocity (PWV) is the noninvasive gold standard measurement of arterial stiffness, and associated with incident vascular events in adults. It is unclear if arterial stiffness is accelerated in children living with perinatal HIV (CHIV) who initiate ART early in life. We compared the longitudinal trajectory of PWV in CHIV to children unexposed to HIV. A secondary comparison compared HIV exposed uninfected children (CHEU) to unexposed children.MethodsFour hundred and sixty-five children (141 CHIV, 160 CHEU, 164 unexposed) previously in the children with HIV early antiretroviral therapy (ART) (CHER) and P1060 trials were followed annually at Tygerberg Children's Hospital, South Africa between 2014 and 2020. CHIV initiated ART in infancy or early childhood, with excellent ART adherence and largely sustained viral suppression. The primary outcome was PWV, measured using the Vicorder system, and evaluated using linear mixed effects models.ResultsMedian (interquartile range) age at first PWV measurement was 8.64 (7.7-9.1) years, and median follow-up time 2.9 (1.6-4.0) years. Adjusted analyses showed no significant mean difference in PWV in CHIV and CHEU compared to unexposed [CHIV: 0.101 m/s, 95% confidence interval (CI) -0.012 to 0.214; CHEU: 0.068 m/s, 95% CI -0.047 to 0.183], after adjusting for gender, age, ethnicity, mean arterial pressure, resting average heart rate and family history of cardiovascular disease.ConclusionsEarly-treated CHIV with sustained viral suppression have similar PWV to unexposed children. Excellent adherence and early ART initiation may protect against cardiovascular disease.

Published
2023

6. Longitudinal comparison of insulin resistance and dyslipidemia in children with and without perinatal HIV infection in South Africa

Author

Davies, Claire, Vaida, Florin, Otwombe, Kennedy, Cotton, Mark F, Browne, Sara, and Innes, Steve

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Atherosclerosis, Cardiovascular, Clinical Research, Pediatric, Diabetes, HIV/AIDS, Pediatric AIDS, Infection, Good Health and Well Being, Female, Pregnancy, Humans, Child, Insulin Resistance, HIV Infections, South Africa, Triglycerides, Dyslipidemias, antiretroviral therapy, children, dyslipidaemia, HIV, Homeostatic Model Assessment of Insulin Resistance, insulin resistance, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology, Biomedical and clinical sciences, Health sciences
Abstract

IntroductionHIV infection is associated with insulin resistance and dyslipidaemia driven by HIV-associated immune dysregulation and antiretroviral therapy (ART). Children living with perinatally acquired HIV (CHIV) face many decades of exposure to these factors. We evaluated the longitudinal trajectory of insulin resistance and dyslipidaemia in CHIV and HIV-exposed uninfected children (CHEU), compared with children HIV-unexposed (CHU).MethodsFour hundred and eighty-five children (141 CHIV, 169 CHEU, 175 CHU) aged 5-16 years, previously part of CHER and P1060 trials, were followed annually at Tygerberg Children's Hospital, South Africa. The primary outcome was Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes included low-density lipoprotein (LDL) cholesterol, triglyceride-to-HDL ratio, android fat mass and SBP. Outcomes were evaluated using linear mixed effects models, adjusting for potential confounders.ResultsCHIV had 73% greater HOMA-IR than CHU in ages 6-8 years (95% CI 15.9-158.2%, P

Published
2023

7. Infants Receiving Very Early Antiretroviral Therapy Have High CD4 Counts in the First Year of Life

Author

Nelson, Bryan S, Tierney, Camlin, Persaud, Deborah, Jao, Jennifer, Cotton, Mark F, Bryson, Yvonne, Coletti, Anne, Ruel, Theodore D, Spector, Stephen A, Reding, Christina, Bacon, Kira, Costello, Diane, Perlowski, Charlotte, Cruz, Maria Leticia Santos, Kosgei, Josphat, Majji, Sai, Yin, Dwight E, Jean-Philippe, Patrick, Chadwick, Ellen G, and Team, for the IMPAACT P1115

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Lung, Infectious Diseases, Clinical Research, Pneumonia & Influenza, HIV/AIDS, Clinical Trials and Supportive Activities, Pediatric, Pneumonia, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Humans, Infant, HIV Infections, Pneumonia, Pneumocystis, Antiretroviral Therapy, Highly Active, Anti-HIV Agents, Anti-Retroviral Agents, CD4 Lymphocyte Count, Pneumocystis carinii, Pneumocystis jirovecii pneumonia, cotrimoxazole, neonatal, HIV, CD4, IMPAACT P1115 Team, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

We followed 54 infants with in utero HIV after initiating very early antiretroviral treatment. At weeks 24 and 48, ≥80% had CD4 ≥1500 cells/mm3 and CD4% ≥25%. Routine Pneumocystis jirovecii pneumonia prophylaxis in the first year of life may not be necessary for all very early treated infants.Clinical trials registrationNCT02140255.

Published
2023

9. CONTRIBUTORS

Author

Abahuje, Egide, primary, Abrahim, Orit, additional, Adetifa, Ifedayo M.O., additional, Ajjampur, Sitara S.R., additional, Alexander, Suceena, additional, PhD, Chiara Altare,, additional, Alves, Fabiana, additional, Andrianaivoarimanana, Voahangy, additional, Angelakis, Emmanouil, additional, Aronson, Jeffrey K., additional, Atukorala, Inoshi G., additional, Baily, Guy, additional, Baker, Stephen, additional, Barrett, Alan D.T., additional, Basnyat, Buddha, additional, Bastawrous, Andrew, additional, Bates, Imelda, additional, Bausch, Daniel G., additional, Baxter, Cheryl, additional, Beare, Nicholas A.V., additional, Beeching, Nick J., additional, Bekker, Linda-Gail, additional, Berlin, Anita, additional, FRS, Zulfiqar A. Bhutta, additional, Bloom, David E., additional, Blumberg, Lucille, additional, Boelaert, Marleen, additional, Brett-Major, David, additional, Brooker, Simon J., additional, Brouwer, Matthijs C., additional, Brunetti, Enrico, additional, Bull, Susan, additional, Bundy, Donald A.P., additional, Burri, Christian, additional, Bustinduy, Amaya L., additional, Caillet, Céline, additional, Chai, Jong Yil, additional, Chang, Thashi, additional, Chappuis, François, additional, Chibi, Buyisile, additional, Chiodini, Peter L., additional, Chowdhury, Rajiv, additional, Chowdhury, Sudipta Dhar, additional, Clemens, John D., additional, Cooke, Graham S., additional, Cotton, Mark F., additional, Currie, Bart J., additional, Cusack, Tomas-Paul, additional, Dance, David A.B., additional, Davis, Emily H., additional, Day, Nicholas P.J., additional, Deen, Jacqueline, additional, Dondorp, Arjen M., additional, Dünser, Martin W., additional, Eitzen, Edward, additional, Chebib, Hassan El, additional, Enria, Delia, additional, Faust, Christina, additional, Fekadu, Abebaw, additional, Fink, Günther, additional, Fischer, Peter U., additional, Fletcher, Tom, additional, Franco-Paredes, Carlos, additional, French, Neil, additional, Frumkin, Howard, additional, Garcia, Hector H., additional, Gerada, Alessandro, additional, Glass, Roger I., additional, Gordon, Stephen B., additional, Gottstein, Bruno, additional, Goyal, Alpesh, additional, Grey, Jonathan, additional, Gupta, Yashdeep, additional, Haines, Andy, additional, Hampson, Katie, additional, Hanlon, Charlotte, additional, Harrison, Mark, additional, Haswell, Melissa R., additional, Hawkesworth, Sophie, additional, Hay, Roderick J., additional, Heckmann, Jeannine M., additional, Heimesaat, Markus M., additional, Henao-Martínez, Andrés F., additional, Hien, Tran Tinh, additional, Hoerauf, Achim, additional, Irfan, Omar, additional, PhD, Euzebiusz Jamrozik, additional, Jobe, Modou, additional, John, George T., additional, Jones, Nick K., additional, Jones, Malcolm K., additional, Junghanss, Thomas, additional, Kaewkes, Sasithorn, additional, Karim, Quarraisha Abdool, additional, Keiser, Jennifer, additional, Kelly, Paul, additional, Khan, Amira M., additional, King, Charles H., additional, Kishore, Sandeep P., additional, Lang, Trudie, additional, Le, Thuy, additional, Liesenfeld, Oliver, additional, Lockwood, Diana N.J., additional, Mabey, David C.W., additional, Madkour, M. Monir, additional, Manesh, Abi, additional, Masekela, Refiloe, additional, Mäser, Pascal, additional, Mayaud, Philippe, additional, Mbanya, Dora, additional, McCarthy, James S., additional, McCartney, Daniel J., additional, McGready, Rose, additional, McKee, Martin, additional, Mc, Namara, Paul S., additional, Meara, John G., additional, Meintjes, Graeme, additional, Merson, Laura, additional, Mola, Glen, additional, Morassutti, Alessandra L., additional, Morris-Jones, Rachael, additional, Mortimer, Kevin J., additional, Muliyil, Divya Elizabeth, additional, Mumcuoglu, Kosta Y., additional, Munoz, Flor M., additional, Murphy, Adrianna, additional, Mutabingwa, Theonest, additional, Nawa, Yukifumi, additional, Newton, Paul N., additional, Nightingale, Sam, additional, Nokes, D. James, additional, Nosten, François H., additional, O’Hea, Jennifer, additional, Olliaro, Piero, additional, Ong, Jason J., additional, Oommen, Anu Mary, additional, Parashar, Umesh D., additional, Paris, Daniel H., additional, Parker, Michael, additional, Pluschke, Gerd, additional, Preidis, Geoffrey A., additional, Prentice, Andrew M., additional, Quail, Geoffrey, additional, Quinn, Thomas C., additional, Rabie, Helena, additional, Rajashekharaiah, Harsha, additional, Rajerison, Minoarisoa, additional, Ranganathan, Kannan, additional, Raoult, Didier, additional, Rassi,, Anis, additional, Ravi, Vasanthapuram, additional, Reddy, K. Srinath, additional, Rees, Claire, additional, Reynolds, Steven J., additional, Richter, Joachim, additional, Rijken, Marcus J., additional, Riviello, Robert, additional, Robinson, Janet, additional, Salazar, Juan C., additional, Schultz, Marcus J., additional, Schwarz, Dan, additional, Sendagire, Ibrahim, additional, Sharma, Savitri, additional, Shawon, Shajedur Rahman, additional, Singh, Bhagteshwar, additional, Sithithaworn, Paiboon, additional, Siwila, Joyce, additional, Solomon, Tom, additional, Spiegel, Paul, additional, Sridhar, Devi, additional, Sripa, Banchob, additional, Srour, M. Leila, additional, Stojković, Marija, additional, Strader, Christopher, additional, Suárez, Jose A., additional, Sundar, Shyam, additional, Tamarozzi, Francesca, additional, Tandon, Nikhil, additional, Tate, Jacqueline E., additional, Thachil, Jecko, additional, Thomson, Madeleine C., additional, Thwaites, Guy, additional, Thwaites, C. Louise, additional, van Daalen, Kim R., additional, Beek, Diederik van de, additional, van Doorn, H. Rogier, additional, Vega-Lopez, Francisco, additional, von Seidlein, MD, PhD, Lorenz, additional, Wakeham, Katie, additional, Walker, Stephen L., additional, Wallace, Ryan M., additional, Ward, Honorine, additional, Warrell, David A., additional, Weber, Tim Frederik, additional, Weil, Gary J., additional, White, Nicholas J., additional, White, MB Ch, B, Graham B., additional, Wong, Vanessa, additional, Wood, Robin, additional, Wood, Georgina, additional, Wyllie, Sarah, additional, Yacoub, Sophie, additional, Yen, Lam Minh, additional, Young, Paul R., additional, and Zafren, Ken, additional

Published
2024
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10. Influence of NAT2 Genotype and Maturation on Isoniazid Exposure in Low-Birth-Weight and Preterm Infants With or Without Human Immunodeficiency Virus (HIV) Exposure

Author

Béranger, Agathe, Bekker, Adrie, Solans, Belén P, Cotton, Mark F, Mirochnick, Mark, Violari, Avy, Wang, Jiajia, Cababasay, Mae, Wiesner, Lubbe, Browning, Renee, Moye, Jack, Capparelli, Edmund V, and Savic, Radojka M

Subjects
Paediatrics, Biomedical and Clinical Sciences, Perinatal Period - Conditions Originating in Perinatal Period, Preterm, Low Birth Weight and Health of the Newborn, Prevention, Pediatric, Infectious Diseases, Infant Mortality, Reproductive health and childbirth, Good Health and Well Being, Antitubercular Agents, Arylamine N-Acetyltransferase, Child, Preschool, Genotype, HIV, HIV Infections, Humans, Infant, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Isoniazid, Tuberculosis, neonate, pediatric, tuberculosis, N-acetyl-isoniazid, pharmacokinetics, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

BackgroundIsoniazid (INH) metabolism depends on the N-acetyl transferase 2 (NAT2) enzyme, whose maturation process remains unknown in low birth weight (LBW) and preterm infants. We aimed to assess INH exposure and safety in infants receiving oral tuberculosis prevention.MethodsThis population pharmacokinetics (PK) analysis used INH and N-acetyl-isoniazid (ACL) concentrations in infants (BW ≤ 4 kg), including preterm, with follow-up for 6 months. PK parameters were described using nonlinear mixed effects modeling. Simulations were performed to assess INH exposure and optimal dosing regimens, using 2 targets: Cmax at 3-6 mg/L and area under the curve (AUC) ≥ 10.52 mg h/L.ResultsWe included 57 infants (79% preterm, 84% LBW) in the PK analysis, with a median (range) gestational age of 34 (28.7-39.4) weeks. At the time of sampling, postnatal age was 2.3 (0.2-7.3) months and weight (WT) was 3.7 (0.9-9.3) kg. NAT2 genotype was available in 43 (75.4%) patients (10 slow, 26 intermediate, and 7 fast metabolizers). Ninety percent of NAT2 maturation was attained by 4.4 post-natal months. WT, postmenstrual age, and NAT2 genotype significantly influenced INH exposure, with a 5-fold difference in AUC between slow and fast metabolizers for the same dose. INH appeared safe across the broad range of exposure for 61 infants included in the safety analysis.ConclusionsIn LBW/preterm infants, INH dosing needs frequent adjustment to account for growth and maturation. Pharmacogenetics-based dosing regimens is the most powerful approach to deliver safe and equalized exposures for all infants, because NAT2 genotype highly impacts INH pharmacokinetic variability.

Published
2022

11. Pharmacokinetics and safety of coformulated bictegravir, emtricitabine, and tenofovir alafenamide in children aged 2 years and older with virologically suppressed HIV: a phase 2/3, open-label, single-arm study

Author

Rodriguez, Carina A, Natukunda, Eva, Strehlau, Renate, Venter, Esme L, Rungmaitree, Supattra, Cunningham, Coleen K, Lalloo, Umesh, Kosalaraksa, Pope, HellstrÖm, Elizabeth, Liberty, Afaaf, McGrath, Eric J, Kaur, Meenu, Leisegang, Rory, Hindman, Jason T, Vieira, Vinicius A, Kersey, Kathryn, Cotton, Mark F, Rakhmanina, Natella, and Gaur, Aditya H

Published
2024
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13. Paediatric abacavir–lamivudine fixed-dose dispersible tablets and ritonavir-boosted lopinavir granules in neonates exposed to HIV (PETITE study): an open-label, two-stage, single-arm, phase 1/2, pharmacokinetic and safety trial

Author

Bekker, Adrie, Salvadori, Nicolas, Rabie, Helena, du Toit, Samantha, Than-in-at, Kanchana, Groenewald, Marisa, Cressey, Ratchada, Nielsen, James, Capparelli, Edmund V, Lallemant, Marc, Cotton, Mark F, and Cressey, Tim R

Published
2024
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14. HIV-1 reservoir size after neonatal antiretroviral therapy and the potential to evaluate antiretroviral-therapy-free remission (IMPAACT P1115): a phase 1/2 proof-of-concept study

Author

Persaud, Deborah, Bryson, Yvonne, Nelson, Bryan S, Tierney, Camlin, Cotton, Mark F, Coletti, Anne, Jao, Jennifer, Spector, Stephen A, Mirochnick, Mark, Capparelli, Edmund V, Costello, Diane, Szewczyk, Joseph, Nicodimus, Nicol, Stranix-Chibanda, Lynda, Kekitiinwa, Adeodata R, Korutaro, Violet, Reding, Christina, Carrington, Mary N, Majji, Sai, Yin, Dwight E, Jean-Philippe, Patrick, and Chadwick, Ellen G

Published
2024
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19. Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

Author

Mehar (nee Abdulla), Amina Farhana, Abraham, Pattamukkil, Abrams, Elaine, Acero, Judith, Agaba, Gerald Muzorah, Ahimbisibwe, Grace, Ainebyoona, Barbara, Akobye, Winnie, Akhalwaya, Yasmeen, Akoojee, Nazim, Ali, Shabinah S., Amuge, Pauline, Andrea, Catherine, Muñoz Fernandez, Maria Angeles, Ankunda, Rogers, Rutebarika, Diana Antonia, Anugulruengkitt, Suvaporn, Apollo, Tsitsi, Archary, Moherndran, Arendze, Ronelle, Ategeka, Juliet, Atim, Eunice, Atwine, Lorna, Babiker, Abdel, Babirye, Sarah, Babu, Enock, Bagirigomwa, Edward, Baita, Angella, Balamusani, David, Baliram, Patsy, Baliruno, David, Ball, Colin, Balwa, Henry, Bamford, Alasdair, Bandi, Srini, Barker, Dominique, Barlow-Mosha, Linda, Bbuye, Dickson, Begum, Shazia, Behuhuma, Osee, Bernays, Sarah, Besigye, Rogers, Bester, Maria, Bhiri, Joyline, Bilardi, Davide, Bird, Kristien, Bollen, Pauline, Borg, Chiara, Borges Da Silva, Anne-Marie, Brown, Jackie, Bruno, Elena, Bunupuradah, Torsak, Burger, David, Buthelezi, Nomzamo, Bwakura-Dangarembizi, Mutsa, Byaruhanga, Africanus, Calvert, Joanna, Casey, Petronelle, Cassim, Haseena, Cebekhulu, Sphiwee, Chailert, Sanuphong, Chalermpantmetagul, Suwalai, Chamjamrat, Wanna, Chan, Man, Chandiwana, Precious, Chankun, Thannapat, Chanthaburanun, Sararut, Chanto, Nuttawut, Chidziva, Ennie, Chikowore, Minenhle, Chimanzi, Joy, Chinwong, Dujrudee, Chitongo, Stuart, Chitsamatanga, Moses, Choga, Joshua, Chutima, Duangrat, Clayden, Polly, Coelho, Alexandra, Colbers, Angela, Compagnucci, Alexandra, Constança Mendes, Ana, Conway, Magda, Cotton, Mark F., Crawley, Jane, Cressey, Tim R., Crisp, Jacky, Matos, Ana Cristina, Dadan, Sumaya, Daglish, Jacqui, Danaviah, Siva, Daniel, Tseleng, De Rossi, Anita, Denjanta, Sukanda, Dobbels, Els, Dowie, Maria, Dube, Prosper, Dube, Benedictor, Dudakia, Nimisha, Elwana, Alice, Epalza, Cristina, Eram, David, Erasmus, Juan, Erim, Peter, Escosa Garcia, Luis, Essack, Zaakirah, Estepa, Carolina, Etima, Monica, Fernandes, Alexandre, Fernandez, Maite, Fitzgerald, Felicity, Flynn, Jacquie, Ford, Deborah, Fortuny Guasch, Claudia, Foster, Caroline, Fourie, George, Fourie, Yolandie, Foxall, Sophie, Frank, Derusha, Gandhi, Kate, Garcia, India, Gartner, Kathleen, Gasa, Joshua, Gasa, Gugu, Giaquinto, Carlo, Gibb, Diana M., Gomez Rico, Coral, Gomez-Pena, Daniel, Gondo, Secrecy, Goodman, Anna, Gorreti Nakalema, Maria, Gozhora, Winnie, Greetanukroh, Pisut, Gregorio Maranon, Biobanco, Grossele, Tiziana, Gwande, Shamiso, Gwaze, Tapiwa, Gwenzi, Tsitsi, Hakim, James, Hakiza, Emmanuel, Kaka, Abdul Hamid, Harley, Ashley, Isaacs, Mornay, Isabirye, Richard, Ishemunyoro, Wilber, Jacobs, Tom, Jafta, Lungile, Jamil, Nasir, Janse van Rensburg, Anita Janse, Jeaven, Vinesh, Mellado Peña, Maria José, Jourdain, Gonzague, Juliet, Katabalwa, Jumpimai, Thidarat, Junkaew, Raungwit, Jupimai, Thidarat, Kaahwa, Winfred, Kabasonga, Mildred, Kaboggoza, Olivia, Kadhuba, Rose Jacqueline, Kaewbundit, Ampika, Kaewmamueng, Kanyanee, Kafufu, Bosco, Kakayi, Brenda, Kamboua, Phakamas, Kanjanavanit, Suparat, Kasangaki, Gladys, Kasipong, Naruporn, Kasozi, Miriam, Kataike, Hajira, Katemba, Chrispus, Kaudha, Elizabeth, Kekane, Nkata, Kekitiinwa, Adeodata R., Keminyeto, Edridah, Khamduang, Woottichai, Khamjakkaew, Warunee, Khamkon, Jiraporn, Khannak, Sasipass, Khatngam, Orapin, Khayanchoomnoom, Tassawan, Khumalo, Busi, Khunene, Mirriam, Khusuwan, Suwimon, Kibalama, Phionah, Kibenge, Robinah, Kirabira, Anthony, Kityo, Cissy M., Kiyimba, Lameck, Klein, Nigel, Klinprung, Soraya, Kobbe, Robin, Kobusingye, Olivia, Kobusungye, Josephine, Kongponoi, Areerat, Königs, Christoph, Koole, Olivier, Kouakam, Christelle, Krueduangkam, Nitinart, Kruenual, Namthip, Kunjaroenrut, Nuananong, Kyambadde, Raymonds, Kyobutungi, Priscilla, Kyomuhendo, Flavia, Kyomukama, Erinah, Lakha, Reshma, Langa, Cleopatra, Laomanit, Laddawan, Lebotsa, Emily, Leenasirimakul, Prattana, Lekku, Lawrence, Lensen, Sarah, Leroy, Valériane, Li, Jin, Liberty, Afaaf, Limplertjareanwanich, Juthamas, Little, Emma, Lugemwa, Abbas, Lutalo, Ezra, Jimenez, Jose Luis, Lyall, Hermione, MacDonald, Candice, Machache, Gladness, Madlala, Penelope, Madonsela, Tryphina, Maduna, Nomfundo, Maena, Joel, Mahanontharit, Apicha, Makanga, Collin, Makola, Candice, Makumbi, Shafic, Malgraaf, Lucille, Mamiane, Angelous, Mantkowski, Felicia, Mapfumo, Wendy, Marques, Laura, Mugagga, Agnes Mary, Maseko, Lindiwe, Masienyane, Tshepiso, Mathiba, Ruth, Matimba, Farai, Mawlana, Sajeeda, Mayanja, Emmanuel, Mayat, Fatima, Mbabazi, Ritah, Mbadaliga, Nokuthula, Mbasani, Faith, McClaughlin, Kathleen, McIlleron, Helen, Meethaisong, Watchara, Mendez Garcia, Patricia, Miwanda, Annet, Miranda, Carlota, Mkhize, Siphiwe, Mmolawa, Kgosimang, Mngqibisa, Rosie, Mohamed, Fatima, Moloantoa, Tumelo, Monametsi, Maletsatsi, Montero, Samuel, Moore, Cecilia L., Mosia, Rejoice, Moyo, Columbus, Mthethwa, Mumsy, Mudzingwa, Shepherd, Mudzviti, Tawona, Mujuru, Hilda, Mujyambere, Emmanuel, Mukanganiki, Trust, Mukisa Williams, Cynthia, Mulder, Mark, Mulima, Disan, Mulindwa, Alice, Mumbiro, Vivian, Mupambireyi, Zivai, Murciano Cabeza, Alba, Murungi, Herbert, Murungu, Dorothy, Musarurwa, Sandra, Musiime, Victor, Musiime, Alex V., Musisi, Maria, Musoke, Philippa, Musoke Nakirya, Barbara, Musoro, Godfrey, Musumba, Sharif, Mustafa, Sobia, Mutsai, Shirley, Mwesigwa Rubondo, Phyllis, Naabalamba, Mariam, Nagawa, Immaculate, Naidoo, Allemah, Nakabuye, Shamim, Nakabuye, Sarah, Nakalanzi, Sarah, Nalubwama, Justine, Nalugo, Annet, Nalusiba, Stella, Namajja, Clementine, Namanda, Sylvia, Namayanja, Paula, Nambi, Esther, Namuddu, Rachael Kikabi, Namukwaya, Stella, Namuli, Florence, Namusanje, Josephine, Namwanje, Rosemary, Nanan-kanjee, Anusha, Nanduudu, Annet, Nankunda, Charity, Baddokwaya, Joanita Nankya, Nannungi, Maria, Nansamba, Winnie, Nanthapisal, Kesdao, Nanyonjo, Juliet, Na-Rajsima, Sathaporn, Nasaazi, Claire, Nascimento, Helena, Nastouli, Eleni, Songtaweesin, Wipaporn Natalie, Nathoo, Kusum, Natuhurira, Ian, Nazzinda, Rashidah, Ncgaba, Thabisa, Ndigendawani, Milly, Ndlovu, Makhosonke, Nentsa, Georgina, Ngampiyaskul, Chaiwat, Ngcobo, Ntombenhle, Ngo Giang Huong, Nicole, Ngwaru, Pia, Nhema, Ruth, Ninsiima, Emily, Ninsiima, Gloria, Nkalo Phiri, Misheck, Noguera Julian, Antoni, Nolan, Monica, Noppakaorattanamanee, Thornthun, Nsibuka Kisekka, Muzamil, Nsirim, Eniola, Nundlal, Rashina, Nunes, Rosita, Nyantsa, Lungile, Nyati, Mandisa, O'Riordan, Sean, Ocitti Labeja, Paul, Odoch, Denis, Oguntimehin, Rachel, Ojok, Martin, Onen, Geoffrey, Orange, Wilma, Ounchanum, Pradthana, Ouma, Benson, Padrao, Andreia, Pako, Deborah, Parker, Anna, Pasko-Szcech, Malgorzata, Patel, Reena, Peongjakta, Rukchanok, Petpranee, Turian, Phillips, Tasmin, Philps, Jackie, Picault, Laura, Pieterse, Sonja, Pinheiro, Helena, Pongprapass, Supawadee, Pozniak, Anton, Prendergast, Andrew, Prieto Tato, Luis, Puangmalai, Patcharee, Puthanakit, Thanyawee, Rakgokong, Modiehi, Ramos, Helena, Ramsagar, Nastassja, Rau, Cornelius, Riault, Yoann, Rojo Conejo, Pablo, Clark, Basiimwa Roy, Rubanga, Eddie, Rubinga, Baker, Ruklao, Chutima, Runarassamee, Pattira, Saenjum, Chalermpong, Saewtrakool, Chayakorn, Saidi, Yacine, Sainz Costa, Talia, Saisaengjan, Chutima, Sakwa, Rebecca, Sarfati, Tatiana, Sbisi, Noshalaza, Scheppers, Dihedile, Schultze-Strasser, Stephan, Schulze-Sturm, Ulf, Scott, Karen, Seeley, Janet, Serunjogi, Robert, Sewnarain, Leora, Shakeshaft, Clare, Sidhoo, Subashinie, Shibemba, Mercy, Shingadia, Delane, Singh, Sheleika, Sirirungsi, Wasna, Sithebe, Sibongile, Smit, Theresa, Smith, Kurt, Smuts, Marlize, Spyer, Moira, Sripaoraya, Worathip, Srirompotong, Ussanee, Srisuk, Warunee, Ssenyonga, Mark, Sudsaard, Patamawadee, Sukrakanchana, Praornsuda, Tearsansern, Pathanee, Teixeira, Carla, Than-in-at, Kanchana, Thapwai, Thitiwat, Thaweesombat, Yupawan, Thewsoongnoen, Jutarat, Thiébaut, Rodolphe, Thomason, Margaret, Thrasyvoulou, Laura, Thungkham, Khanungnit, Tikabibamu, Judith, Tinago, Gloria, Trairat, Ketmookda, Tudor-Williams, Gareth, Tukamushaba, Mercy, Tukwasibwe, Deogratiuos, Tumusiime, Julius, Tuna, Joana, Turkova, Anna, Turner, Rebecca, Udomvised, Arttasid, Vadee, Aasia, Van Huyssteen, Hesti, Van Looy, Nadine, Variava, Ebrahim, Vaughan-Gordon, Yvonne, Vecchia, Giulio, Violari, Avy, Vowden, Richard, Waalewijn, Hylke, Wampamba, Rebecca, Welch, Steve, Weller, Ian, Weza, Sibusisiwe, White, Ellen, White, Ian, Widuch, Kaja, Wilkes, Helen, Wimonklang, Sookpanee, Wynne, Ben, Yingyong, Pacharaporn, Nakawungu, Zaam Zinda, Zuidewind, Peter, Chan, Man K, Bollen, Pauline D J, Bwakura-Dangarembizi, Mutsa F, Kekitiinwa, Adeodata R, Cotton, Mark F, Ahimbisibwe, Grace Miriam, Ali, Shabinah, Kityo, Cissy M, Ferrand, Rashida A, Gibb, Diana M, and Burger, David M

Published
2022
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21. Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial

Author

Mehar (nee Abdulla), Amina Farhana, Abraham, Pattamukkil, Abrams, Elaine, Acero, Judith, Agaba, Gerald Muzorah, Ahimbisibwe, Grace, Ainebyoona, Barbara, Akobye, Winnie, Akhalwaya, Yasmeen, Akoojee, Nazim, Ali, Shabinah S., Amuge, Pauline, Andrea, Catherine, Muñoz Fernandez, Maria Angeles, Ankunda, Rogers, Rutebarika, Diana Antonia, Anugulruengkitt, Suvaporn, Apollo, Tsitsi, Archary, Moherndran, Arendze, Ronelle, Ategeka, Juliet, Atim, Eunice, Atwine, Lorna, Babiker, Abdel, Babirye, Sarah, Babu, Enock, Bagirigomwa, Edward, Baita, Angella, Balamusani, David, Baliram, Patsy, Baliruno, David, Ball, Colin, Balwa, Henry, Bamford, Alasdair, Bandi, Srini, Barker, Dominique, Barlow-Mosha, Linda, Bbuye, Dickson, Begum, Shazia, Behuhuma, Osee, Bernays, Sarah, Besigye, Rogers, Bester, Maria, Bhiri, Joyline, Bilardi, Davide, Bird, Kristien, Bollen, Pauline, Borg, Chiara, Borges Da Silva, Anne-Marie, Brown, Jackie, Bruno, Elena, Bunupuradah, Torsak, Burger, David, Buthelezi, Nomzamo, Bwakura-Dangarembizi, Mutsa, Byaruhanga, Africanus, Calvert, Joanna, Casey, Petronelle, Cassim, Haseena, Cebekhulu, Sphiwee, Chailert, Sanuphong, Chalermpantmetagul, Suwalai, Chamjamrat, Wanna, Chan, Man, Chandiwana, Precious, Chankun, Thannapat, Chanthaburanun, Sararut, Chanto, Nuttawut, Chidziva, Ennie, Chikowore, Minenhle, Chimanzi, Joy, Chinwong, Dujrudee, Chitongo, Stuart, Chitsamatanga, Moses, Choga, Joshua, Chutima, Duangrat, Clayden, Polly, Coelho, Alexandra, Colbers, Angela, Compagnucci, Alexandra, Constança Mendes, Ana, Conway, Magda, Cotton, Mark F, Crawley, Jane, Cressey, Tim R, Crisp, Jacky, Matos, Ana Cristina, Dadan, Sumaya, Daglish, Jacqui, Danaviah, Siva, Daniel, Tseleng, De Rossi, Anita, Denjanta, Sukanda, Dobbels, Els, Dowie, Maria, Dube, Prosper, Dube, Benedictor, Dudakia, Nimisha, Elwana, Alice, Epalza, Cristina, Eram, David, Erasmus, Juan, Erim, Peter, Escosa Garcia, Luis, Essack, Zaakirah, Estepa, Carolina, Etima, Monica, Fernandes, Alexandre, Fernandez, Maite, Fitzgerald, Felicity, Flynn, Jacquie, Ford, Deborah, Fortuny Guasch, Claudia, Foster, Caroline, Fourie, George, Fourie, Yolandie, Foxall, Sophie, Frank, Derusha, Gandhi, Kate, Garcia, India, Gartner, Kathleen, Gasa, Joshua, Gasa, Gugu, Giaquinto, Carlo, Gibb, Diana M, Gomez Rico, Coral, Gomez-Pena, Daniel, Gondo, Secrecy, Goodman, Anna, Gorreti Nakalema, Maria, Gozhora, Winnie, Greetanukroh, Pisut, Gregorio Maranon, Biobanco, Grossele, Tiziana, Gwande, Shamiso, Gwaze, Tapiwa, Gwenzi, Tsitsi, Hakim, James, Hakiza, Emmanuel, Kaka, Abdul Hamid, Harley, Ashley, Isaacs, Mornay, Isabirye, Richard, Ishemunyoro, Wilber, Jacobs, Tom, Jafta, Lungile, Jamil, Nasir, Janse van Rensburg, Anita Janse, Jeaven, Vinesh, Mellado Peña, Maria José, Jourdain, Gonzague, Juliet, Katabalwa, Jumpimai, Thidarat, Junkaew, Raungwit, Jupimai, Thidarat, Kaahwa, Winfred, Kabasonga, Mildred, Kaboggoza, Olivia, Kadhuba, Rose Jacqueline, Kaewbundit, Ampika, Kaewmamueng, Kanyanee, Kafufu, Bosco, Kakayi, Brenda, Kamboua, Phakamas, Kanjanavanit, Suparat, Kasangaki, Gladys, Kasipong, Naruporn, Kasozi, Miriam, Kataike, Hajira, Katemba, Chrispus, Kaudha, Elizabeth, Kekane, Nkata, Kekitiinwa, Adeodata R, Keminyeto, Edridah, Khamduang, Woottichai, Khamjakkaew, Warunee, Khamkon, Jiraporn, Khannak, Sasipass, Khatngam, Orapin, Khayanchoomnoom, Tassawan, Khumalo, Busi, Khunene, Mirriam, Khusuwan, Suwimon, Kibalama, Phionah, Kibenge, Robinah, Kirabira, Anthony, Kityo, Cissy M, Kiyimba, Lameck, Klein, Nigel, Klinprung, Soraya, Kobbe, Robin, Kobusingye, Olivia, Kobusungye, Josephine, Kongponoi, Areerat, Königs, Christoph, Koole, Olivier, Kouakam, Christelle, Krueduangkam, Nitinart, Kruenual, Namthip, Kunjaroenrut, Nuananong, Kyambadde, Raymonds, Kyobutungi, Priscilla, Kyomuhendo, Flavia, Kyomukama, Erinah, Lakha, Reshma, Langa, Cleopatra, Laomanit, Laddawan, Lebotsa, Emily, Leenasirimakul, Prattana, Lekku, Lawrence, Lensen, Sarah, Leroy, Valériane, Li, Jin, Liberty, Afaaf, Limplertjareanwanich, Juthamas, Little, Emma, Lugemwa, Abbas, Lutalo, Ezra, Jimenez, Jose Luis, Lyall, Hermione, MacDonald, Candice, Machache, Gladness, Madlala, Penelope, Madonsela, Tryphina, Maduna, Nomfundo, Maena, Joel, Mahanontharit, Apicha, Makanga, Collin, Makola, Candice, Makumbi, Shafic, Malgraaf, Lucille, Mamiane, Angelous, Mantkowski, Felicia, Mapfumo, Wendy, Marques, Laura, Mugagga, Agnes Mary, Maseko, Lindiwe, Masienyane, Tshepiso, Mathiba, Ruth, Matimba, Farai, Mawlana, Sajeeda, Mayanja, Emmanuel, Mayat, Fatima, Mbabazi, Ritah, Mbadaliga, Nokuthula, Mbasani, Faith, McClaughlin, Kathleen, McIlleron, Helen, Meethaisong, Watchara, Mendez Garcia, Patricia, Miwanda, Annet, Miranda, Carlota, Mkhize, Siphiwe, Mmolawa, Kgosimang, Mngqibisa, Rosie, Mohamed, Fatima, Moloantoa, Tumelo, Monametsi, Maletsatsi, Montero, Samuel, Moore, Cecilia L, Mosia, Rejoice, Moyo, Columbus, Mthethwa, Mumsy, Mudzingwa, Shepherd, Mudzviti, Tawona, Mujuru, Hilda, Mujyambere, Emmanuel, Mukanganiki, Trust, Mukisa Williams, Cynthia, Mulder, Mark, Mulima, Disan, Mulindwa, Alice, Mumbiro, Vivian, Mupambireyi, Zivai, Murciano Cabeza, Alba, Murungi, Herbert, Murungu, Dorothy, Musarurwa, Sandra, Musiime, Victor, Musiime, Alex V, Musisi, Maria, Musoke, Philippa, Musoke Nakirya, Barbara, Musoro, Godfrey, Musumba, Sharif, Mustafa, Sobia, Mutsai, Shirley, Mwesigwa Rubondo, Phyllis, Naabalamba, Mariam, Nagawa, Immaculate, Naidoo, Allemah, Nakabuye, Shamim, Nakabuye, Sarah, Nakalanzi, Sarah, Nalubwama, Justine, Nalugo, Annet, Nalusiba, Stella, Namajja, Clementine, Namanda, Sylvia, Namayanja, Paula, Nambi, Esther, Namuddu, Rachael Kikabi, Namukwaya, Stella, Namuli, Florence, Namusanje, Josephine, Namwanje, Rosemary, Nanan-kanjee, Anusha, Nanduudu, Annet, Nankunda, Charity, Baddokwaya, Joanita Nankya, Nannungi, Maria, Nansamba, Winnie, Nanthapisal, Kesdao, Nanyonjo, Juliet, Na-Rajsima, Sathaporn, Nasaazi, Claire, Nascimento, Helena, Nastouli, Eleni, Songtaweesin, Wipaporn Natalie, Nathoo, Kusum, Natuhurira, Ian, Nazzinda, Rashidah, Ncgaba, Thabisa, Ndigendawani, Milly, Ndlovu, Makhosonke, Nentsa, Georgina, Ngampiyaskul, Chaiwat, Ngcobo, Ntombenhle, Ngo Giang Huong, Nicole, Ngwaru, Pia, Nhema, Ruth, Ninsiima, Emily, Ninsiima, Gloria, Nkalo Phiri, Misheck, Noguera Julian, Antoni, Nolan, Monica, Noppakaorattanamanee, Thornthun, Nsibuka Kisekka, Muzamil, Nsirim, Eniola, Nundlal, Rashina, Nunes, Rosita, Nyantsa, Lungile, Nyati, Mandisa, O'Riordan, Sean, Ocitti Labeja, Paul, Odoch, Denis, Oguntimehin, Rachel, Ojok, Martin, Onen, Geoffrey, Orange, Wilma, Ounchanum, Pradthana, Ouma, Benson, Padrao, Andreia, Pako, Deborah, Parker, Anna, Pasko-Szcech, Malgorzata, Patel, Reena, Peongjakta, Rukchanok, Petpranee, Turian, Phillips, Tasmin, Philps, Jackie, Picault, Laura, Pieterse, Sonja, Pinheiro, Helena, Pongprapass, Supawadee, Pozniak, Anton, Prendergast, Andrew, Prieto Tato, Luis, Puangmalai, Patcharee, Puthanakit, Thanyawee, Rakgokong, Modiehi, Ramos, Helena, Ramsagar, Nastassja, Rau, Cornelius, Riault, Yoann, Rojo Conejo, Pablo, Clark, Basiimwa Roy, Rubanga, Eddie, Rubinga, Baker, Ruklao, Chutima, Runarassamee, Pattira, Saenjum, Chalermpong, Saewtrakool, Chayakorn, Saidi, Yacine, Sainz Costa, Talia, Saisaengjan, Chutima, Sakwa, Rebecca, Sarfati, Tatiana, Sbisi, Noshalaza, Scheppers, Dihedile, Schultze-Strasser, Stephan, Schulze-Sturm, Ulf, Scott, Karen, Seeley, Janet, Serunjogi, Robert, Sewnarain, Leora, Shakeshaft, Clare, Sidhoo, Subashinie, Shibemba, Mercy, Shingadia, Delane, Singh, Sheleika, Sirirungsi, Wasna, Sithebe, Sibongile, Smit, Theresa, Smith, Kurt, Smuts, Marlize, Spyer, Moira, Sripaoraya, Worathip, Srirompotong, Ussanee, Srisuk, Warunee, Ssenyonga, Mark, Sudsaard, Patamawadee, Sukrakanchana, Praornsuda, Tearsansern, Pathanee, Teixeira, Carla, Than-in-at, Kanchana, Thapwai, Thitiwat, Thaweesombat, Yupawan, Thewsoongnoen, Jutarat, Thiébaut, Rodolphe, Thomason, Margaret, Thrasyvoulou, Laura, Thungkham, Khanungnit, Tikabibamu, Judith, Tinago, Gloria, Trairat, Ketmookda, Tudor-Williams, Gareth, Tukamushaba, Mercy, Tukwasibwe, Deogratiuos, Tumusiime, Julius, Tuna, Joana, Turkova, Anna, Turner, Rebecca, Udomvised, Arttasid, Vadee, Aasia, Van Huyssteen, Hesti, Van Looy, Nadine, Variava, Ebrahim, Vaughan-Gordon, Yvonne, Vecchia, Giulio, Violari, Avy, Vowden, Richard, Waalewijn, Hylke, Wampamba, Rebecca, Welch, Steve, Weller, Ian, Weza, Sibusisiwe, White, Ellen, White, Ian, Widuch, Kaja, Wilkes, Helen, Wimonklang, Sookpanee, Wynne, Ben, Yingyong, Pacharaporn, Nakawungu, Zaam Zinda, Zuidewind, Peter, Ahimbisibwe, Grace Miriam, Mosia, Nozibusiso Rejoice, Fortuny, Clàudia, Bwakura-Dangarembizi, Mutsa F, Mujuru, Hilda A, Kityo, Cissy, Ferrand, Rashida A, and Rojo, Pablo

Published
2023
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22. Pharmacokinetics and safety of early nevirapine-based antiretroviral therapy for neonates at high risk for perinatal HIV infection: a phase 1/2 proof of concept study

Author

Ruel, Theodore D, Capparelli, Edmund V, Tierney, Camlin, Nelson, Bryan S, Coletti, Anne, Bryson, Yvonne, Cotton, Mark F, Spector, Stephen A, Mirochnick, Mark, LeBlanc, Rebecca, Reding, Christina, Zimmer, Bonnie, Persaud, Deborah, Bwakura-Dangarembizi, Mutsa, Naidoo, Kimesh L, Hazra, Rohan, Jean-Philippe, Patrick, and Chadwick, Ellen G

Subjects
Paediatrics, Medical Microbiology, Biomedical and Clinical Sciences, Clinical Trials and Supportive Activities, HIV/AIDS, Pediatric AIDS, Preterm, Low Birth Weight and Health of the Newborn, Infant Mortality, Infectious Diseases, Clinical Research, Pediatric, Patient Safety, Perinatal Period - Conditions Originating in Perinatal Period, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Reproductive health and childbirth, Good Health and Well Being, Anti-HIV Agents, Female, Gestational Age, HIV Infections, Humans, Infant, Infant, Newborn, Infectious Disease Transmission, Vertical, Male, Nevirapine, Pregnancy, Pregnancy Complications, Infectious, Proof of Concept Study, Prospective Studies, Reverse Transcriptase Inhibitors, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundWith increasing intention to treat HIV as early as possible, evidence to confirm the safety and therapeutic drug concentrations of a nevirapine-based antiretroviral regimen in the early neonatal period is needed. This study aims to establish dosing of nevirapine for very early treatment of HIV-exposed neonates at high risk of HIV acquisition.MethodsIMPAACT P1115 is a multinational phase 1/2 proof-of-concept study in which presumptive treatment for in-utero HIV infection is initiated within 48 h of birth in HIV-exposed neonates at high risk of HIV acquisition. Participants were neonates who were at least 34 weeks gestational age at birth and enrolled within 48 h of birth, born to women with presumed or confirmed HIV infection who had not received antiretrovirals during this pregnancy. The regimen consisted of two nucleoside reverse transcriptase inhibitors plus nevirapine dosed at 6 mg/kg twice daily for term neonates (≥37 weeks gestational age) or 4 mg/kg twice daily for 1 week and 6 mg/kg twice daily thereafter for preterm neonates (34 to

Published
2021

24. Evaluating pediatric tuberculosis dosing guidelines: A model-based individual data pooled analysis

Author

Galileya, Lufina Tsirizani, Wasmann, Roeland E., Chabala, Chishala, Rabie, Helena, Lee, Janice, Njahira Mukui, Irene, Hesseling, Anneke, Zar, Heather, Aarnoutse, Rob, Turkova, Anna, Gibb, Diana, Cotton, Mark F., McIlleron, Helen, and Denti, Paolo

Subjects
HIV (Viruses) -- Analysis -- Models, Pediatrics -- Models -- Analysis, Efavirenz -- Analysis -- Models, Rifampin -- Analysis -- Models, Pyrazinamide -- Models -- Analysis, Highly active antiretroviral therapy -- Models -- Analysis, Tuberculosis -- Analysis -- Models, Public health -- Analysis -- Models, Biological sciences, University of Cape Town, World Health Organization
Abstract

Background The current World Health Organization (WHO) pediatric tuberculosis dosing guidelines lead to suboptimal drug exposures. Identifying factors altering the exposure of these drugs in children is essential for dose optimization. Pediatric pharmacokinetic studies are usually small, leading to high variability and uncertainty in pharmacokinetic results between studies. We pooled data from large pharmacokinetic studies to identify key covariates influencing drug exposure to optimize tuberculosis dosing in children. Methods and findings We used nonlinear mixed-effects modeling to characterize the pharmacokinetics of rifampicin, isoniazid, and pyrazinamide, and investigated the association of human immunodeficiency virus (HIV), antiretroviral therapy (ART), drug formulation, age, and body size with their pharmacokinetics. Data from 387 children from South Africa, Zambia, Malawi, and India were available for analysis; 47% were female and 39% living with HIV (95% on ART). Median (range) age was 2.2 (0.2 to 15.0) years and weight 10.9 (3.2 to 59.3) kg. Body size (allometry) was used to scale clearance and volume of distribution of all 3 drugs. Age affected the bioavailability of rifampicin and isoniazid; at birth, children had 48.9% (95% confidence interval (CI) [36.0%, 61.8%]; p < 0.001) and 64.5% (95% CI [52.1%, 78.9%]; p < 0.001) of adult rifampicin and isoniazid bioavailability, respectively, and reached full adult bioavailability after 2 years of age for both drugs. Age also affected the clearance of all drugs (maturation), children reached 50% adult drug clearing capacity at around 3 months after birth and neared full maturation around 3 years of age. While HIV per se did not affect the pharmacokinetics of first-line tuberculosis drugs, rifampicin clearance was 22% lower (95% CI [13%, 28%]; p < 0.001) and pyrazinamide clearance was 49% higher (95% CI [39%, 57%]; p < 0.001) in children on lopinavir/ritonavir; isoniazid bioavailability was reduced by 39% (95% CI [32%, 45%]; p < 0.001) when simultaneously coadministered with lopinavir/ritonavir and was 37% lower (95% CI [22%, 52%]; p < 0.001) in children on efavirenz. Simulations of 2010 WHO-recommended pediatric tuberculosis doses revealed that, compared to adult values, rifampicin exposures are lower in most children, except those younger than 3 months, who experience relatively higher exposure for all drugs, due to immature clearance. Increasing the rifampicin doses in children older than 3 months by 75 mg for children weighing 25 kg could improve rifampicin exposures. Our analysis was limited by the differences in availability of covariates among the pooled studies. Conclusions Children older than 3 months have lower rifampicin exposures than adults and increasing their dose by 75 or 150 mg could improve therapy. Altered exposures in children with HIV is most likely caused by concomitant ART and not HIV per se. The importance of the drug-drug interactions with lopinavir/ritonavir and efavirenz should be evaluated further and considered in future dosing guidance. Trial registration ClinicalTrials.gov registration numbers; NCT02348177, NCT01637558, ISRCTN63579542, Author(s): Lufina Tsirizani Galileya 1,2, Roeland E. Wasmann 1, Chishala Chabala 1,3,4, Helena Rabie 5, Janice Lee 6, Irene Njahira Mukui 6, Anneke Hesseling 7, Heather Zar 8, Rob Aarnoutse [...]

Published
2023
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25. Safety and immunogenicity of VPM1002 versus BCG in South African newborn babies: a randomised, phase 2 non-inferiority double-blind controlled trial

Author

Cotton, Mark F, Madhi, Shabir A, Luabeya, Angelique K, Tameris, Michele, Hesseling, Anneke C, Shenje, Justin, Schoeman, Elisma, Hatherill, Mark, Desai, Sajjad, Kapse, Dhananjay, Brückner, Sina, Koen, Anthonet, Jose, Lisa, Moultrie, Andrew, Bhikha, Sutika, Walzl, Gerhard, Gutschmidt, Andrea, Kotze, Leigh A, Allies, Devon L, Loxton, Andre G, Shaligram, Umesh, Abraham, Maria, Johnstone, Hilary, Grode, Leander, Kaufmann, S H E, and Kulkarni, Prasad S

Published
2022
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27. Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial

Author

Mehar (nee Abdulla), Amina Farhana, Abraham, Pattamukkil, Abrams, Elaine, Acero, Judith, Agaba, Gerald Muzorah, Ahimbisibwe, Grace, Ainebyoona, Barbara, Akobye, Winnie, Akhalwaya, Yasmeen, Akoojee, Nazim, Ali, Shabinah S., Amuge, Pauline, Andrea, Catherine, Muñoz Fernandez, Maria Angeles, Ankunda, Rogers, Rutebarika, Diana Antonia, Anugulruengkitt, Suvaporn, Apollo, Tsitsi, Archary, Moherndran, Arendze, Ronelle, Ategeka, Juliet, Atim, Eunice, Atwine, Lorna, Babiker, Abdel, Babirye, Sarah, Babu, Enock, Bagirigomwa, Edward, Baita, Angella, Balamusani, David, Baliram, Patsy, Baliruno, David, Ball, Colin, Balwa, Henry, Bamford, Alasdair, Bandi, Srini, Barker, Dominique, Barlow-Mosha, Linda, Bbuye, Dickson, Begum, Shazia, Behuhuma, Osee, Bernays, Sarah, Besigye, Rogers, Bester, Maria, Bhiri, Joyline, Bilardi, Davide, Bird, Kristien, Bollen, Pauline, Borg, Chiara, Borges Da Silva, Anne-Marie, Brown, Jackie, Bruno, Elena, Bunupuradah, Torsak, Burger, David, Buthelezi, Nomzamo, Bwakura-Dangarembizi, Mutsa, Byaruhanga, Africanus, Calvert, Joanna, Casey, Petronelle, Cassim, Haseena, Cebekhulu, Sphiwee, Chailert, Sanuphong, Chalermpantmetagul, Suwalai, Chamjamrat, Wanna, Chan, Man, Chandiwana, Precious, Chankun, Thannapat, Chanthaburanun, Sararut, Chanto, Nuttawut, Chidziva, Ennie, Chikowore, Minenhle, Chimanzi, Joy, Chinwong, Dujrudee, Chitongo, Stuart, Chitsamatanga, Moses, Choga, Joshua, Chutima, Duangrat, Clayden, Polly, Coelho, Alexandra, Colbers, Angela, Compagnucci, Alexandra, Constança Mendes, Ana, Conway, Magda, Cotton, Mark F., Crawley, Jane, Cressey, Tim R., Crisp, Jacky, Matos, Ana Cristina, Dadan, Sumaya, Daglish, Jacqui, Danaviah, Siva, Daniel, Tseleng, De Rossi, Anita, Denjanta, Sukanda, Dobbels, Els, Dowie, Maria, Dube, Prosper, Dube, Benedictor, Dudakia, Nimisha, Elwana, Alice, Epalza, Cristina, Eram, David, Erasmus, Juan, Erim, Peter, Escosa Garcia, Luis, Essack, Zaakirah, Estepa, Carolina, Etima, Monica, Fernandes, Alexandre, Fernandez, Maite, Fitzgerald, Felicity, Flynn, Jacquie, Ford, Deborah, Fortuny Guasch, Claudia, Foster, Caroline, Fourie, George, Fourie, Yolandie, Foxall, Sophie, Frank, Derusha, Gandhi, Kate, Garcia, India, Gartner, Kathleen, Gasa, Joshua, Gasa, Gugu, Giaquinto, Carlo, Gibb, Diana M., Gomez Rico, Coral, Gomez-Pena, Daniel, Gondo, Secrecy, Goodman, Anna, Gorreti Nakalema, Maria, Gozhora, Winnie, Greetanukroh, Pisut, Gregorio Maranon, Biobanco, Grossele, Tiziana, Gwande, Shamiso, Gwaze, Tapiwa, Gwenzi, Tsitsi, Hakim, James, Hakiza, Emmanuel, Kaka, Abdul Hamid, Harley, Ashley, Isaacs, Mornay, Isabirye, Richard, Ishemunyoro, Wilber, Jacobs, Tom, Jafta, Lungile, Jamil, Nasir, Janse van Rensburg, Anita Janse, Jeaven, Vinesh, Mellado Peña, Maria José, Jourdain, Gonzague, Juliet, Katabalwa, Jumpimai, Thidarat, Junkaew, Raungwit, Jupimai, Thidarat, Kaahwa, Winfred, Kabasonga, Mildred, Kaboggoza, Olivia, Kadhuba, Rose Jacqueline, Kaewbundit, Ampika, Kaewmamueng, Kanyanee, Kafufu, Bosco, Kakayi, Brenda, Kamboua, Phakamas, Kanjanavanit, Suparat, Kasangaki, Gladys, Kasipong, Naruporn, Kasozi, Miriam, Kataike, Hajira, Katemba, Chrispus, Kaudha, Elizabeth, Kekane, Nkata, Kekitiinwa, Adeodata R., Keminyeto, Edridah, Khamduang, Woottichai, Khamjakkaew, Warunee, Khamkon, Jiraporn, Khannak, Sasipass, Khatngam, Orapin, Khayanchoomnoom, Tassawan, Khumalo, Busi, Khunene, Mirriam, Khusuwan, Suwimon, Kibalama, Phionah, Kibenge, Robinah, Kirabira, Anthony, Kityo, Cissy M., Kiyimba, Lameck, Klein, Nigel, Klinprung, Soraya, Kobbe, Robin, Kobusingye, Olivia, Kobusungye, Josephine, Kongponoi, Areerat, Königs, Christoph, Koole, Olivier, Kouakam, Christelle, Krueduangkam, Nitinart, Kruenual, Namthip, Kunjaroenrut, Nuananong, Kyambadde, Raymonds, Kyobutungi, Priscilla, Kyomuhendo, Flavia, Kyomukama, Erinah, Lakha, Reshma, Langa, Cleopatra, Laomanit, Laddawan, Lebotsa, Emily, Leenasirimakul, Prattana, Lekku, Lawrence, Lensen, Sarah, Leroy, Valériane, Li, Jin, Liberty, Afaaf, Limplertjareanwanich, Juthamas, Little, Emma, Lugemwa, Abbas, Lutalo, Ezra, Jimenez, Jose Luis, Lyall, Hermione, MacDonald, Candice, Machache, Gladness, Madlala, Penelope, Madonsela, Tryphina, Maduna, Nomfundo, Maena, Joel, Mahanontharit, Apicha, Makanga, Collin, Makola, Candice, Makumbi, Shafic, Malgraaf, Lucille, Mamiane, Angelous, Mantkowski, Felicia, Mapfumo, Wendy, Marques, Laura, Mugagga, Agnes Mary, Maseko, Lindiwe, Masienyane, Tshepiso, Mathiba, Ruth, Matimba, Farai, Mawlana, Sajeeda, Mayanja, Emmanuel, Mayat, Fatima, Mbabazi, Ritah, Mbadaliga, Nokuthula, Mbasani, Faith, McClaughlin, Kathleen, McIlleron, Helen, Meethaisong, Watchara, Mendez Garcia, Patricia, Miwanda, Annet, Miranda, Carlota, Mkhize, Siphiwe, Mmolawa, Kgosimang, Mngqibisa, Rosie, Mohamed, Fatima, Moloantoa, Tumelo, Monametsi, Maletsatsi, Montero, Samuel, Moore, Cecilia L., Mosia, Rejoice, Moyo, Columbus, Mthethwa, Mumsy, Mudzingwa, Shepherd, Mudzviti, Tawona, Mujuru, Hilda, Mujyambere, Emmanuel, Mukanganiki, Trust, Mukisa Williams, Cynthia, Mulder, Mark, Mulima, Disan, Mulindwa, Alice, Mumbiro, Vivian, Mupambireyi, Zivai, Murciano Cabeza, Alba, Murungi, Herbert, Murungu, Dorothy, Musarurwa, Sandra, Musiime, Victor, Musiime, Alex V., Musisi, Maria, Musoke, Philippa, Musoke Nakirya, Barbara, Musoro, Godfrey, Musumba, Sharif, Mustafa, Sobia, Mutsai, Shirley, Mwesigwa Rubondo, Phyllis, Naabalamba, Mariam, Nagawa, Immaculate, Naidoo, Allemah, Nakabuye, Shamim, Nakabuye, Sarah, Nakalanzi, Sarah, Nalubwama, Justine, Nalugo, Annet, Nalusiba, Stella, Namajja, Clementine, Namanda, Sylvia, Namayanja, Paula, Nambi, Esther, Namuddu, Rachael Kikabi, Namukwaya, Stella, Namuli, Florence, Namusanje, Josephine, Namwanje, Rosemary, Nanan-kanjee, Anusha, Nanduudu, Annet, Nankunda, Charity, Baddokwaya, Joanita Nankya, Nannungi, Maria, Nansamba, Winnie, Nanthapisal, Kesdao, Nanyonjo, Juliet, Na-Rajsima, Sathaporn, Nasaazi, Claire, Nascimento, Helena, Nastouli, Eleni, Songtaweesin, Wipaporn Natalie, Nathoo, Kusum, Natuhurira, Ian, Nazzinda, Rashidah, Ncgaba, Thabisa, Ndigendawani, Milly, Ndlovu, Makhosonke, Nentsa, Georgina, Ngampiyaskul, Chaiwat, Ngcobo, Ntombenhle, Ngo Giang Huong, Nicole, Ngwaru, Pia, Nhema, Ruth, Ninsiima, Emily, Ninsiima, Gloria, Nkalo Phiri, Misheck, Noguera Julian, Antoni, Nolan, Monica, Noppakaorattanamanee, Thornthun, Nsibuka Kisekka, Muzamil, Nsirim, Eniola, Nundlal, Rashina, Nunes, Rosita, Nyantsa, Lungile, Nyati, Mandisa, O'Riordan, Sean, Ocitti Labeja, Paul, Odoch, Denis, Oguntimehin, Rachel, Ojok, Martin, Onen, Geoffrey, Orange, Wilma, Ounchanum, Pradthana, Ouma, Benson, Padrao, Andreia, Pako, Deborah, Parker, Anna, Pasko-Szcech, Malgorzata, Patel, Reena, Peongjakta, Rukchanok, Petpranee, Turian, Phillips, Tasmin, Philps, Jackie, Picault, Laura, Pieterse, Sonja, Pinheiro, Helena, Pongprapass, Supawadee, Pozniak, Anton, Prendergast, Andrew, Prieto Tato, Luis, Puangmalai, Patcharee, Puthanakit, Thanyawee, Rakgokong, Modiehi, Ramos, Helena, Ramsagar, Nastassja, Rau, Cornelius, Riault, Yoann, Rojo Conejo, Pablo, Clark, Basiimwa Roy, Rubanga, Eddie, Rubinga, Baker, Ruklao, Chutima, Runarassamee, Pattira, Saenjum, Chalermpong, Saewtrakool, Chayakorn, Saidi, Yacine, Sainz Costa, Talia, Saisaengjan, Chutima, Sakwa, Rebecca, Sarfati, Tatiana, Sbisi, Noshalaza, Scheppers, Dihedile, Schultze-Strasser, Stephan, Schulze-Sturm, Ulf, Scott, Karen, Seeley, Janet, Serunjogi, Robert, Sewnarain, Leora, Shakeshaft, Clare, Sidhoo, Subashinie, Shibemba, Mercy, Shingadia, Delane, Singh, Sheleika, Sirirungsi, Wasna, Sithebe, Sibongile, Smit, Theresa, Smith, Kurt, Smuts, Marlize, Spyer, Moira, Sripaoraya, Worathip, Srirompotong, Ussanee, Srisuk, Warunee, Ssenyonga, Mark, Sudsaard, Patamawadee, Sukrakanchana, Praornsuda, Tearsansern, Pathanee, Teixeira, Carla, Than-in-at, Kanchana, Thapwai, Thitiwat, Thaweesombat, Yupawan, Thewsoongnoen, Jutarat, Thiébaut, Rodolphe, Thomason, Margaret, Thrasyvoulou, Laura, Thungkham, Khanungnit, Tikabibamu, Judith, Tinago, Gloria, Trairat, Ketmookda, Tudor-Williams, Gareth, Tukamushaba, Mercy, Tukwasibwe, Deogratiuos, Tumusiime, Julius, Tuna, Joana, Turkova, Anna, Turner, Rebecca, Udomvised, Arttasid, Vadee, Aasia, Van Huyssteen, Hesti, Van Looy, Nadine, Variava, Ebrahim, Vaughan-Gordon, Yvonne, Vecchia, Giulio, Violari, Avy, Vowden, Richard, Waalewijn, Hylke, Wampamba, Rebecca, Welch, Steve, Weller, Ian, Weza, Sibusisiwe, White, Ellen, White, Ian, Widuch, Kaja, Wilkes, Helen, Wimonklang, Sookpanee, Wynne, Ben, Yingyong, Pacharaporn, Nakawungu, Zaam Zinda, Zuidewind, Peter, Mujuru, Hilda A, Kityo, Cissy M, Turner, Rebecca M, Ali, Shabinah, Nathoo, Kusum J, Mosala, Modehei, Kekitiinwa, Adeodata R, Rojo, Pablo, and Gibb, Diana M

Published
2022
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29. Study APV20002: Safety and Efficacy Results Through Week 684 for Pediatric Participants Living with HIV-1 Treated with Ritonavir-Boosted Fosamprenavir Oral Solution–Based Antiretroviral Therapy.

Author

Ross, Lisa L., Cotton, Mark F., Cassim, Haseena, Garges, Harmony P., van Dijkman, Sven C., Morarji, Kishen, Karthika, Supriya, Danehower, Susan, Radford, Jacob, and Butcher, David

Abstract

APV20002 was a multicenter, international, open-label study that began in 2003 investigating the pharmacokinetics, efficacy, and safety of ritonavir-boosted fosamprenavir (FPV/r) oral solution (OS) in combination with nucleoside reverse transcriptase inhibitor-based antiretroviral therapy (ART) in participants living with HIV-1 aged 4 weeks to <2 years with a primary endpoint at Week 48 (48W). Participants in APV20002 could continue in the study post-48W until FPV OS was locally available in their countries. Children were required to discontinue after reaching >39 kg or if FPV OS had no clinical benefit. Fifty-nine participants were enrolled; 5/59 received a single FPV OS visit for pharmacokinetic determinations. Most (38/54; 70%) were antiretroviral experienced; 39/59 participants had >48 weeks on treatment, 4/39 of whom discontinued after 48 weeks due to an adverse event (AE). At 48W, 88% of participants had HIV-1 RNA <400 copies/mL by Observed analysis; the proportion with HIV-1 RNA <400 copies/mL remained high (84%−100%) through Week 684. The median CD4+ cell count was 1,235 cells/mm3 [n = 51] at baseline, 1,690 cells/mm3 (n = 41) at Week 48, and 1,280 cells/mm3 (n = 21) at Week 180. From baseline to Week 684, 54/59 (92%) participants had ≥1 treatment-emergent AE regardless of causality; 42/59 (71%) had a treatment-emergent grade 2–4 AE, predominantly maximum toxicity: grade 2; 21/59 (36%) and 21/59 (36%) had severe or grade 3/4 AEs. From baseline to Week 684, 14/54 (26%) participants met virologic failure (VF) criteria, 9/14 before 48W. HIV from 1/9 VFs through 48W developed treatment-emergent reduced susceptibility to FPV and 1/9 to lamivudine/emtricitabine. Post-48W, 4/5 participants with VF had phenotype results; all were still susceptible to all study drugs at VF. In conclusion, FPV OS-based ART was efficacious and generally well tolerated in this long-running pediatric study through 684 weeks of treatment, with a safety profile consistent with experience in adults and older children. [ABSTRACT FROM AUTHOR]

Published
2024
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30. Lamivudine dosing for preterm infants exposed to HIV: a population pharmacokinetic modelling and simulation study.

Author

Bekker, Adrie, Capparelli, Edmund V, Mirochnick, Mark, Clarke, Diana F, Cotton, Mark F, Shapiro, Roger, McCarthy, Katie, Moye, Jack, Violari, Avy, Chokephaibulkit, Kulkanya, Abrams, Elaine, Penazzato, Martina, Ruel, Theodore D, and Cressey, Tim R

Subjects
NEWBORN infants, PREMATURE infants, LAMIVUDINE, GESTATIONAL age, INFANTS
Abstract

Objectives To develop a pragmatic twice daily lamivudine dosing strategy for preterm infants from 24 to 37 completed weeks of gestation. Methods Data were combined from eight pharmacokinetic studies in neonates and infants receiving lamivudine oral solution. A population pharmacokinetic model was developed using non-linear mixed effects regression. Different lamivudine dosing strategies, stratified by gestational age at birth (GA) bands, were simulated in a virtual population of preterm infants, aimed at maintaining lamivudine drug exposures (AUC0-12) within a reference target range of 2.95 to 13.25 µg·h/mL, prior to switching to WHO-weight band doses when ≥4 weeks of age and weighing ≥3 kg. Results A total of 154 infants (59% female) contributed 858 lamivudine plasma concentrations. Median (range) GA at birth was 38 (27–41) weeks. At the time of first pharmacokinetic sampling infants were older with median postnatal age (PNA) of 6.3 (0.52–26.6) weeks. Lamivudine concentrations were described by a one-compartment model, with CL/F and V /F allometrically scaled to weight. Maturation of CL/F was described using an Emax model based on PNA. CL/F was also adjusted on GA to allow extrapolation for extreme prematurity. Simulations predicted an optimal lamivudine dosing for infants GA ≥24 to <30 weeks of 2 mg/kg twice daily from birth until weighing 3 kg; and for GA ≥30 to <37 weeks, 2 mg/kg twice daily for the first 4 weeks of life, followed by 4 mg/kg twice daily until weighing 3 kg. Conclusions Model-based predictions support twice daily pragmatic GA band dosing of lamivudine for preterm infants, but clinical validation is warranted. [ABSTRACT FROM AUTHOR]

Published
2024
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33. Optimizing the World Health Organization algorithm for HIV vertical transmission risk assessment by adding maternal self-reported antiretroviral therapy adherence

Author

Fernández-Luis, Sheila, Lain, Maria Grazia, Serna-Pascual, Miquel, Domínguez-Rodríguez, Sara, Kuhn, Louise, Liberty, Afaaf, Barnabas, Shaun, Lopez-Varela, Elisa, Otwombe, Kennedy, Danaviah, Siva, Nastouli, Eleni, Palma, Paolo, Cotugno, Nicola, Spyer, Moira, Giannuzzi, Viviana, Giaquinto, Carlo, Violari, Avy, Cotton, Mark F., Nhampossa, Tacilta, Klein, Nigel, Ramsagar, Nastassja, van Rensburg, Anita Janse, Behuhuma, Osee, Vaz, Paula, Maiga, Almoustapha Issiaka, Oletto, Andrea, Naniche, Denise, Rossi, Paolo, Rojo, Pablo, and Tagarro, Alfredo

Published
2022
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34. Borrowing information across patient subgroups in clinical trials, with application to a paediatric trial

Author

Turner, Rebecca M., Turkova, Anna, Moore, Cecilia L., Bamford, Alasdair, Archary, Moherndran, Barlow-Mosha, Linda N., Cotton, Mark F., Cressey, Tim R., Kaudha, Elizabeth, Lugemwa, Abbas, Lyall, Hermione, Mujuru, Hilda A., Mulenga, Veronica, Musiime, Victor, Rojo, Pablo, Tudor-Williams, Gareth, Welch, Steven B., Gibb, Diana M., Ford, Deborah, and White, Ian R.

Published
2022
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38. Cognitive outcomes at ages seven and nine years in South African children from the children with HIV early antiretroviral (CHER) trial: a longitudinal investigation

Author

Wyhe, Kaylee S. van, Laughton, Barbara, Cotton, Mark F., Meintjes, Ernesta M., van der Kouwe, Andre J.W., Boivin, Michael J., Kidd, Martin, and Thomas, Kevin G.F.

Subjects
HIV infection in children -- Drug therapy -- Complications and side effects, Antiviral agents -- Testing, Cognition disorders -- Risk factors, Pediatric research, Health
Abstract

Introduction: Many children living with HIV (CLWH) display impaired cognition. Although early combination antiretrovira therapy (ART) produces improved cognitive outcomes, more long-term outcome data are needed. After concluding the Children with HIV Early antiRetroviral (CHER) trial in 2011, we investigated cognitive performance, at seven and nine years of age. Participants had been randomized to deferred ART (ART-Def; n = 22); immediate time-limited ART for 40 weeks (ART40W; n = 30) and immediate time-limited ART for 96 weeks (ART-96W; n = 18). We also recruited HIV-exposed uninfected (CHEU; n = 28) and HIV-unexposed (CHU; n = 35) children. Methods: Data were collected between May 2012 and December 2017. Mixed-model repeated-measures ANOVAs assessed differences over time between CLWH (ART-40W, ART-96W and ART-Def) and CHIV- CHEU and CHU between ART-Early (ART-40W and ART-96W), ART-Def, CHEU and CHU; and between ART-40W, ART-96W, ART-Def, CHEU and CHU. Results: All comparisons found significant effects of Time for most outcome variables (better scores at nine than at seven years; ps < 0.05). The first ANOVAs found that for (a) motor dexterity, CLWH performed worse than CHIV- at seven years (p < 0.001) but improved to equivalence at nine years, (b) visual-spatial processing and problem solving, only CLWH (p < 0.04) showed significant performance improvement over time and (c) working memory and executive function, CLWH performed worse than CHIV- at both seven and nine years (p = 0.03 and 0.04). The second ANOVAs found that for (a) working memory, CHU performed better than ART-Early and CHEU (p < 0.01 and 0.17). Similarly, for motor dexterity, ART-Def performed worse than ART-96W, CHEU and CHU at seven years (p < 0.04, 0.20). Conclusions: Although neurocognitive developmental trajectories for treatment groups and controls were largely similar (i.e. performance improvements from 7 to 9), all ART-treated children, regardless of treatment arm, remain at risk for cognitive deficits over early school ages. Although the nature of these deficits may change as cognitive development proceeds, there are potential negative consequences for these children's future learning, reasoning and adaptive functioning. Keywords: antiretroviral therapy; The Children with HIV Early Antiretrovira Therapy (CHER) trial; HIV/AIDS; HIV-associated neurocognitive impairment; paediatric HIV; working memory, 1 | INTRODUCTION Despite treatment advances, many children living with HIV (CLWH) have impaired cognitive performance [1-3]. Early and severe HIV-related neurological manifestations such as encephalopathy, increase the risk of [...]

Published
2021
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40. Tuberculosis infection and disease in South African adolescents with perinatally acquired HIV on antiretroviral therapy: a cohort study

Author

Frigati, Lisa J., Wilkinson, Katalin A., Leroux, Stanzi, Brown, Karryn, Ruzive, Sheena, Githinji, Leah, Petersen, Wonita, Belard, Sabine, Cotton, Mark F., Myer, Landon, and Zar, Heather J.

Subjects
HIV infection in children -- Drug therapy -- Complications and side effects, Tuberculosis -- Risk factors -- Statistics -- Demographic aspects, Adolescent medicine -- Research, Pediatric research, Health
Abstract

Introduction: There are limited data on Tuberculosis (TB) in adolescents with perinatally acquired HIV (APHIV). We examined the incidence and determinants of TB infection and disease in the Cape Town Adolescent Antiretroviral Cohort (CTAAC). Methods: Youth between nine and fourteen years on antiretroviral therapy (ART) for more than six months in public sector care, and age-matched HIV-negative adolescents, were enrolled between July 2013 through March 2015 and followed six-monthly Data were censored on 31 October 2018. Symptom screening, chest radiograph, viral load, CD4 count, QuantiFERON (QFT) and sputum for Xpert MTB/RIF, microscopy, culture and sensitivity were performed annually. TB infection was defined by a QFT of >0.35 IU/mL. TB diagnosis was defined as confirmed (culture or Xpert MTB/RIF positive) or unconfirmed (clinica diagnosis and started on TB treatment). Analyses examined the incidence and determinants of TB infection and disease. Results: Overall 496 HIV+ and 103 HIV-negative participants (median age at enrolment 12 years (interquartile range, IQR 10.6 to 13.3) were followed for a median of 3.1 years (IQR 3.0 to 3.4); 50% (298/599) were male. APHIV initiated ART at median age 4.4 years (IQR 2.1 to 7.6). At enrolment, 376/496 (76%) had HIV viral load Conclusions: High incidence rates of TB disease occur in APHIV despite similar QFT conversion rates to HIV-negative adolescents. Strategies to prevent TB in this vulnerable group must be strengthened. Keywords: tuberculosis; coinfection; incidence; adolescents; perinatal; HIV, 1 | INTRODUCTION Adolescence is a period of increased risk for both Mycobacterium tuberculosis (Mtb) infection and tuberculosis disease (TB), compared to the pre-adolescent period [1,2]. Globally, an estimated 1.8 [...]

Published
2021
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41. Early Proteomic and Innate Immunity Profiles: A Footprint of Increased Mortality Risk In Infants Living with Hiv From Three African Countries

Author

Morrocchi, Elena, primary, Pascucci, Giuseppe Rubens, additional, Cotugno, Nicola, additional, Pighi, Chiara, additional, Domínguez-Rodríguez, Sara, additional, Petrara, Maria Raffaella, additional, Tagarro, Alfredo, additional, Kuhn, Louise, additional, Cotton, Mark F., additional, Otwombe, Kennedy, additional, Lain, Maria Grazia, additional, Vaz, Paula, additional, Barnabas, Shaun L., additional, Spyer, Moira J., additional, Lopez Varela, Elisa, additional, Fernandez-Luis, Sheila, additional, Nhampossa, Tacilta, additional, Maiga, Almoustapha Issiaka, additional, Dolo, Oumar, additional, De Rossi, Anita, additional, Rojo, Pablo, additional, Giaquinto, Carlo, additional, Lichterfeld, Matthias, additional, Violari, Avy, additional, Smit, Theresa, additional, Behuhuma, Osee, additional, Klein, Nigel, additional, De Armas, Lesley, additional, Pahwa, Savita, additional, Rossi, Paolo, additional, Palma, Paolo, additional, and Consortium, EPIICAL, additional

Published
2024
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42. Next generation sequencing improves detection of drug resistance mutations in infants after PMTCT failure

Author

Fisher, Randall G, Smith, Davey M, Murrell, Ben, Slabbert, Ruhan, Kirby, Bronwyn M, Edson, Clair, Cotton, Mark F, Haubrich, Richard H, Pond, Sergei L Kosakovsky, and Van Zyl, Gert U

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Pediatric, HIV/AIDS, Prevention, Perinatal Period - Conditions Originating in Perinatal Period, Genetics, Biotechnology, Antimicrobial Resistance, Sexually Transmitted Infections, Infectious Diseases, Infection, Good Health and Well Being, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Computational Biology, Drug Resistance, Viral, Female, Genotype, HIV Infections, HIV-1, High-Throughput Nucleotide Sequencing, Humans, Infant, Infant, Newborn, Infectious Disease Transmission, Vertical, Male, Microbial Sensitivity Tests, Mutation, Mutation Rate, RNA, Viral, Retrospective Studies, Viral Load, Prevention of mother to child transmission, Non-nucleoside reverse transcriptase inhibitor resistance, HIV-1 drug resistance, Next generation sequencing, Nevirapine, Minor variant antiretroviral drug resistance mutations, Microbiology, Clinical Sciences, Virology, Clinical sciences, Medical microbiology
Abstract

BackgroundNext generation sequencing (NGS) allows the detection of minor variant HIV drug resistance mutations (DRMs). However data from new NGS platforms after Prevention-of-Mother-to-Child-Transmission (PMTCT) regimen failure are limited.ObjectiveTo compare major and minor variant HIV DRMs with Illumina MiSeq and Life Technologies Ion Personal Genome Machine (PGM) in infants infected despite a PMTCT regimen.Study designWe conducted a cross-sectional study of NGS for detecting DRMs in infants infected despite a zidovudine (AZT) and Nevirapine (NVP) regimen, before initiation of combination antiretroviral therapy. Sequencing was performed on PCR products from plasma samples on PGM and MiSeq platforms. Bioinformatic analyses were undertaken using a codon-aware version of the Smith-Waterman mapping algorithm and a mixture multinomial error filtering statistical model.ResultsOf 15 infants, tested at a median age of 3.4 months after birth, 2 (13%) had non-nucleoside reverse transcriptase inhibitor (NNRTI) DRMs (K103N and Y181C) by bulk sequencing, whereas PGM detected 4 (26%) and MiSeq 5 (30%). NGS enabled the detection of additional minor variant DRMs in the infant with K103N. Coverage and instrument quality scores were higher with MiSeq, increasing the confidence of minor variant calls.ConclusionsNGS followed by bioinformatic analyses detected multiple minor variant DRMs in HIV-1 RT among infants where PMTCT failed. The high coverage of MiSeq and high read quality improved the confidence of identified DRMs and may make this platform ideal for minor variant detection.

Published
2015

47. Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial

Author

Turkova, Anna, primary, White, Ellen, additional, Kekitiinwa, Adeodata R, additional, Mumbiro, Vivian, additional, Kaudha, Elizabeth, additional, Liberty, Afaaf, additional, Ahimbisibwe, Grace Miriam, additional, Moloantoa, Tumelo, additional, Srirompotong, Ussanee, additional, Mosia, Nozibusiso Rejoice, additional, Puthanakit, Thanyawee, additional, Kobbe, Robin, additional, Fortuny, Clàudia, additional, Kataike, Hajira, additional, Bbuye, Dickson, additional, Na-Rajsima, Sathaporn, additional, Coelho, Alexandra, additional, Lugemwa, Abbas, additional, Bwakura-Dangarembizi, Mutsa F, additional, Klein, Nigel, additional, Mujuru, Hilda A, additional, Kityo, Cissy, additional, Cotton, Mark F, additional, Ferrand, Rashida A, additional, Giaquinto, Carlo, additional, Rojo, Pablo, additional, Violari, Avy, additional, Gibb, Diana M, additional, Ford, Deborah, additional, Mehar (nee Abdulla), Amina Farhana, additional, Abraham, Pattamukkil, additional, Abrams, Elaine, additional, Acero, Judith, additional, Agaba, Gerald Muzorah, additional, Ahimbisibwe, Grace, additional, Ainebyoona, Barbara, additional, Akobye, Winnie, additional, Akhalwaya, Yasmeen, additional, Akoojee, Nazim, additional, Ali, Shabinah S., additional, Amuge, Pauline, additional, Andrea, Catherine, additional, Muñoz Fernandez, Maria Angeles, additional, Ankunda, Rogers, additional, Rutebarika, Diana Antonia, additional, Anugulruengkitt, Suvaporn, additional, Apollo, Tsitsi, additional, Archary, Moherndran, additional, Arendze, Ronelle, additional, Ategeka, Juliet, additional, Atim, Eunice, additional, Atwine, Lorna, additional, Babiker, Abdel, additional, Babirye, Sarah, additional, Babu, Enock, additional, Bagirigomwa, Edward, additional, Baita, Angella, additional, Balamusani, David, additional, Baliram, Patsy, additional, Baliruno, David, additional, Ball, Colin, additional, Balwa, Henry, additional, Bamford, Alasdair, additional, Bandi, Srini, additional, Barker, Dominique, additional, Barlow-Mosha, Linda, additional, Begum, Shazia, additional, Behuhuma, Osee, additional, Bernays, Sarah, additional, Besigye, Rogers, additional, Bester, Maria, additional, Bhiri, Joyline, additional, Bilardi, Davide, additional, Bird, Kristien, additional, Bollen, Pauline, additional, Borg, Chiara, additional, Borges Da Silva, Anne-Marie, additional, Brown, Jackie, additional, Bruno, Elena, additional, Bunupuradah, Torsak, additional, Burger, David, additional, Buthelezi, Nomzamo, additional, Bwakura-Dangarembizi, Mutsa, additional, Byaruhanga, Africanus, additional, Calvert, Joanna, additional, Casey, Petronelle, additional, Cassim, Haseena, additional, Cebekhulu, Sphiwee, additional, Chailert, Sanuphong, additional, Chalermpantmetagul, Suwalai, additional, Chamjamrat, Wanna, additional, Chan, Man, additional, Chandiwana, Precious, additional, Chankun, Thannapat, additional, Chanthaburanun, Sararut, additional, Chanto, Nuttawut, additional, Chidziva, Ennie, additional, Chikowore, Minenhle, additional, Chimanzi, Joy, additional, Chinwong, Dujrudee, additional, Chitongo, Stuart, additional, Chitsamatanga, Moses, additional, Choga, Joshua, additional, Chutima, Duangrat, additional, Clayden, Polly, additional, Colbers, Angela, additional, Compagnucci, Alexandra, additional, Constança Mendes, Ana, additional, Conway, Magda, additional, Crawley, Jane, additional, Cressey, Tim R, additional, Crisp, Jacky, additional, Matos, Ana Cristina, additional, Dadan, Sumaya, additional, Daglish, Jacqui, additional, Danaviah, Siva, additional, Daniel, Tseleng, additional, De Rossi, Anita, additional, Denjanta, Sukanda, additional, Dobbels, Els, additional, Dowie, Maria, additional, Dube, Prosper, additional, Dube, Benedictor, additional, Dudakia, Nimisha, additional, Elwana, Alice, additional, Epalza, Cristina, additional, Eram, David, additional, Erasmus, Juan, additional, Erim, Peter, additional, Escosa Garcia, Luis, additional, Essack, Zaakirah, additional, Estepa, Carolina, additional, Etima, Monica, additional, Fernandes, Alexandre, additional, Fernandez, Maite, additional, Fitzgerald, Felicity, additional, Flynn, Jacquie, additional, Fortuny Guasch, Claudia, additional, Foster, Caroline, additional, Fourie, George, additional, Fourie, Yolandie, additional, Foxall, Sophie, additional, Frank, Derusha, additional, Gandhi, Kate, additional, Garcia, India, additional, Gartner, Kathleen, additional, Gasa, Joshua, additional, Gasa, Gugu, additional, Gomez Rico, Coral, additional, Gomez-Pena, Daniel, additional, Gondo, Secrecy, additional, Goodman, Anna, additional, Gorreti Nakalema, Maria, additional, Gozhora, Winnie, additional, Greetanukroh, Pisut, additional, Gregorio Maranon, Biobanco, additional, Grossele, Tiziana, additional, Gwande, Shamiso, additional, Gwaze, Tapiwa, additional, Gwenzi, Tsitsi, additional, Hakim, James, additional, Hakiza, Emmanuel, additional, Kaka, Abdul Hamid, additional, Harley, Ashley, additional, Isaacs, Mornay, additional, Isabirye, Richard, additional, Ishemunyoro, Wilber, additional, Jacobs, Tom, additional, Jafta, Lungile, additional, Jamil, Nasir, additional, Janse van Rensburg, Anita Janse, additional, Jeaven, Vinesh, additional, Mellado Peña, Maria José, additional, Jourdain, Gonzague, additional, Juliet, Katabalwa, additional, Jumpimai, Thidarat, additional, Junkaew, Raungwit, additional, Jupimai, Thidarat, additional, Kaahwa, Winfred, additional, Kabasonga, Mildred, additional, Kaboggoza, Olivia, additional, Kadhuba, Rose Jacqueline, additional, Kaewbundit, Ampika, additional, Kaewmamueng, Kanyanee, additional, Kafufu, Bosco, additional, Kakayi, Brenda, additional, Kamboua, Phakamas, additional, Kanjanavanit, Suparat, additional, Kasangaki, Gladys, additional, Kasipong, Naruporn, additional, Kasozi, Miriam, additional, Katemba, Chrispus, additional, Kekane, Nkata, additional, Keminyeto, Edridah, additional, Khamduang, Woottichai, additional, Khamjakkaew, Warunee, additional, Khamkon, Jiraporn, additional, Khannak, Sasipass, additional, Khatngam, Orapin, additional, Khayanchoomnoom, Tassawan, additional, Khumalo, Busi, additional, Khunene, Mirriam, additional, Khusuwan, Suwimon, additional, Kibalama, Phionah, additional, Kibenge, Robinah, additional, Kirabira, Anthony, additional, Kityo, Cissy M, additional, Kiyimba, Lameck, additional, Klinprung, Soraya, additional, Kobusingye, Olivia, additional, Kobusungye, Josephine, additional, Kongponoi, Areerat, additional, Königs, Christoph, additional, Koole, Olivier, additional, Kouakam, Christelle, additional, Krueduangkam, Nitinart, additional, Kruenual, Namthip, additional, Kunjaroenrut, Nuananong, additional, Kyambadde, Raymonds, additional, Kyobutungi, Priscilla, additional, Kyomuhendo, Flavia, additional, Kyomukama, Erinah, additional, Lakha, Reshma, additional, Langa, Cleopatra, additional, Laomanit, Laddawan, additional, Lebotsa, Emily, additional, Leenasirimakul, Prattana, additional, Lekku, Lawrence, additional, Lensen, Sarah, additional, Leroy, Valériane, additional, Li, Jin, additional, Limplertjareanwanich, Juthamas, additional, Little, Emma, additional, Lutalo, Ezra, additional, Jimenez, Jose Luis, additional, Lyall, Hermione, additional, MacDonald, Candice, additional, Machache, Gladness, additional, Madlala, Penelope, additional, Madonsela, Tryphina, additional, Maduna, Nomfundo, additional, Maena, Joel, additional, Mahanontharit, Apicha, additional, Makanga, Collin, additional, Makola, Candice, additional, Makumbi, Shafic, additional, Malgraaf, Lucille, additional, Mamiane, Angelous, additional, Mantkowski, Felicia, additional, Mapfumo, Wendy, additional, Marques, Laura, additional, Mugagga, Agnes Mary, additional, Maseko, Lindiwe, additional, Masienyane, Tshepiso, additional, Mathiba, Ruth, additional, Matimba, Farai, additional, Mawlana, Sajeeda, additional, Mayanja, Emmanuel, additional, Mayat, Fatima, additional, Mbabazi, Ritah, additional, Mbadaliga, Nokuthula, additional, Mbasani, Faith, additional, McClaughlin, Kathleen, additional, McIlleron, Helen, additional, Meethaisong, Watchara, additional, Mendez Garcia, Patricia, additional, Miwanda, Annet, additional, Miranda, Carlota, additional, Mkhize, Siphiwe, additional, Mmolawa, Kgosimang, additional, Mngqibisa, Rosie, additional, Mohamed, Fatima, additional, Monametsi, Maletsatsi, additional, Montero, Samuel, additional, Moore, Cecilia L, additional, Mosia, Rejoice, additional, Moyo, Columbus, additional, Mthethwa, Mumsy, additional, Mudzingwa, Shepherd, additional, Mudzviti, Tawona, additional, Mujuru, Hilda, additional, Mujyambere, Emmanuel, additional, Mukanganiki, Trust, additional, Mukisa Williams, Cynthia, additional, Mulder, Mark, additional, Mulima, Disan, additional, Mulindwa, Alice, additional, Mupambireyi, Zivai, additional, Murciano Cabeza, Alba, additional, Murungi, Herbert, additional, Murungu, Dorothy, additional, Musarurwa, Sandra, additional, Musiime, Victor, additional, Musiime, Alex V, additional, Musisi, Maria, additional, Musoke, Philippa, additional, Musoke Nakirya, Barbara, additional, Musoro, Godfrey, additional, Musumba, Sharif, additional, Mustafa, Sobia, additional, Mutsai, Shirley, additional, Mwesigwa Rubondo, Phyllis, additional, Naabalamba, Mariam, additional, Nagawa, Immaculate, additional, Naidoo, Allemah, additional, Nakabuye, Shamim, additional, Nakabuye, Sarah, additional, Nakalanzi, Sarah, additional, Nalubwama, Justine, additional, Nalugo, Annet, additional, Nalusiba, Stella, additional, Namajja, Clementine, additional, Namanda, Sylvia, additional, Namayanja, Paula, additional, Nambi, Esther, additional, Namuddu, Rachael Kikabi, additional, Namukwaya, Stella, additional, Namuli, Florence, additional, Namusanje, Josephine, additional, Namwanje, Rosemary, additional, Nanan-kanjee, Anusha, additional, Nanduudu, Annet, additional, Nankunda, Charity, additional, Baddokwaya, Joanita Nankya, additional, Nannungi, Maria, additional, Nansamba, Winnie, additional, Nanthapisal, Kesdao, additional, Nanyonjo, Juliet, additional, Nasaazi, Claire, additional, Nascimento, Helena, additional, Nastouli, Eleni, additional, Songtaweesin, Wipaporn Natalie, additional, Nathoo, Kusum, additional, Natuhurira, Ian, additional, Nazzinda, Rashidah, additional, Ncgaba, Thabisa, additional, Ndigendawani, Milly, additional, Ndlovu, Makhosonke, additional, Nentsa, Georgina, additional, Ngampiyaskul, Chaiwat, additional, Ngcobo, Ntombenhle, additional, Ngo Giang Huong, Nicole, additional, Ngwaru, Pia, additional, Nhema, Ruth, additional, Ninsiima, Emily, additional, Ninsiima, Gloria, additional, Nkalo Phiri, Misheck, additional, Noguera Julian, Antoni, additional, Nolan, Monica, additional, Noppakaorattanamanee, Thornthun, additional, Nsibuka Kisekka, Muzamil, additional, Nsirim, Eniola, additional, Nundlal, Rashina, additional, Nunes, Rosita, additional, Nyantsa, Lungile, additional, Nyati, Mandisa, additional, O'Riordan, Sean, additional, Ocitti Labeja, Paul, additional, Odoch, Denis, additional, Oguntimehin, Rachel, additional, Ojok, Martin, additional, Onen, Geoffrey, additional, Orange, Wilma, additional, Ounchanum, Pradthana, additional, Ouma, Benson, additional, Padrao, Andreia, additional, Pako, Deborah, additional, Parker, Anna, additional, Pasko-Szcech, Malgorzata, additional, Patel, Reena, additional, Peongjakta, Rukchanok, additional, Petpranee, Turian, additional, Phillips, Tasmin, additional, Philps, Jackie, additional, Picault, Laura, additional, Pieterse, Sonja, additional, Pinheiro, Helena, additional, Pongprapass, Supawadee, additional, Pozniak, Anton, additional, Prendergast, Andrew, additional, Prieto Tato, Luis, additional, Puangmalai, Patcharee, additional, Rakgokong, Modiehi, additional, Ramos, Helena, additional, Ramsagar, Nastassja, additional, Rau, Cornelius, additional, Riault, Yoann, additional, Rojo Conejo, Pablo, additional, Clark, Basiimwa Roy, additional, Rubanga, Eddie, additional, Rubinga, Baker, additional, Ruklao, Chutima, additional, Runarassamee, Pattira, additional, Saenjum, Chalermpong, additional, Saewtrakool, Chayakorn, additional, Saidi, Yacine, additional, Sainz Costa, Talia, additional, Saisaengjan, Chutima, additional, Sakwa, Rebecca, additional, Sarfati, Tatiana, additional, Sbisi, Noshalaza, additional, Scheppers, Dihedile, additional, Schultze-Strasser, Stephan, additional, Schulze-Sturm, Ulf, additional, Scott, Karen, additional, Seeley, Janet, additional, Serunjogi, Robert, additional, Sewnarain, Leora, additional, Shakeshaft, Clare, additional, Sidhoo, Subashinie, additional, Shibemba, Mercy, additional, Shingadia, Delane, additional, Singh, Sheleika, additional, Sirirungsi, Wasna, additional, Sithebe, Sibongile, additional, Smit, Theresa, additional, Smith, Kurt, additional, Smuts, Marlize, additional, Spyer, Moira, additional, Sripaoraya, Worathip, additional, Srisuk, Warunee, additional, Ssenyonga, Mark, additional, Sudsaard, Patamawadee, additional, Sukrakanchana, Praornsuda, additional, Tearsansern, Pathanee, additional, Teixeira, Carla, additional, Than-in-at, Kanchana, additional, Thapwai, Thitiwat, additional, Thaweesombat, Yupawan, additional, Thewsoongnoen, Jutarat, additional, Thiébaut, Rodolphe, additional, Thomason, Margaret, additional, Thrasyvoulou, Laura, additional, Thungkham, Khanungnit, additional, Tikabibamu, Judith, additional, Tinago, Gloria, additional, Trairat, Ketmookda, additional, Tudor-Williams, Gareth, additional, Tukamushaba, Mercy, additional, Tukwasibwe, Deogratiuos, additional, Tumusiime, Julius, additional, Tuna, Joana, additional, Turkova, Anna, additional, Turner, Rebecca, additional, Udomvised, Arttasid, additional, Vadee, Aasia, additional, Van Huyssteen, Hesti, additional, Van Looy, Nadine, additional, Variava, Ebrahim, additional, Vaughan-Gordon, Yvonne, additional, Vecchia, Giulio, additional, Vowden, Richard, additional, Waalewijn, Hylke, additional, Wampamba, Rebecca, additional, Welch, Steve, additional, Weller, Ian, additional, Weza, Sibusisiwe, additional, White, Ian, additional, Widuch, Kaja, additional, Wilkes, Helen, additional, Wimonklang, Sookpanee, additional, Wynne, Ben, additional, Yingyong, Pacharaporn, additional, Nakawungu, Zaam Zinda, additional, and Zuidewind, Peter, additional

Published
2023
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50. High prevalence of lipoatrophy in pre-pubertal South African children on antiretroviral therapy: a cross-sectional study

Author

Innes, Steve, Cotton, Mark F, Haubrich, Richard, Conradie, Maria M, van Niekerk, Margaret, Edson, Clair, Rabie, Helena, Jain, Sonia, Sun, Xiaoying, Zöllner, Ekkehard W, Hough, Stephen, and Browne, Sara H

Abstract

Abstract Background Despite changes in WHO guidelines, stavudine is still used extensively for treatment of pediatric HIV in the developing world. Lipoatrophy in sub-Saharan African children can be stigmatizing and have far-reaching consequences. The severity and extent of lipoatrophy in pre-pubertal children living in sub-Saharan Africa is unknown. Methods In this cross-sectional study, children who were 3-12 years old, on antiretroviral therapy and pre-pubertal were recruited from a Family HIV Clinic in South Africa. Lipoatrophy was identified and graded by consensus between two HIV pediatricians using a standardized grading scale. A professional dietician performed formal dietary assessment and anthropometric measurements of trunk and limb fat. Previous antiretroviral exposures were recorded. In a Dual-Energy X-ray Absorbtiometry (DXA) substudy body composition was determined in 42 participants. Results Among 100 recruits, the prevalence of visually obvious lipoatrophy was 36% (95% CI: 27%–45%). Anthropometry and DXA measurements corroborated the clinical diagnosis of lipoatrophy: Both confirmed significant, substantial extremity fat loss in children with visually obvious lipoatrophy, when adjusted for age and sex. Adjusted odds ratio for developing lipoatrophy was 1.9 (95% CI: 1.3 - 2.9) for each additional year of accumulated exposure to standard dose stavudine. Cumulative time on standard dose stavudine was significantly associated with reductions in biceps and triceps skin-fold thickness (p=0.008). Conclusions The prevalence of visually obvious lipoatrophy in pre-pubertal South African children on antiretroviral therapy is high. The amount of stavudine that children are exposed to needs review. Resources are needed to enable low-and-middle-income countries to provide suitable pediatric-formulated alternatives to stavudine-based pediatric regimens. The standard stavudine dose for children may need to be reduced. Diagnosis of lipoatrophy at an early stage is important to allow timeous antiretroviral switching to arrest progression and avoid stigmatization. Diagnosis using visual grading requires training and experience, and DXA and comprehensive anthropometry are not commonly available. A simple objective screening tool is needed to identify early lipoatrophy in resource-limited settings where specialized skills and equipment are not available.

Published
2012

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