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1. Efficacy, Safety, and Tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Results Through Week 96 from IMPAACT 2014

Author

Rungmaitree, Supattra, Aurpibul, Linda, Best, Brookie M, Li, Xiang, Warshaw, Meredith G, Wan, Hong, Tobin, Nicole H, Jumes, Patricia, Leavitt, Randi, McCarthy, Katie, Scheckter, Rachel, Ounchanum, Pradthana, Violari, Avy, Teppler, Hedy, Campbell, Havilland, Krotje, Chelsea, Townley, Ellen, Moye, Jack, Melvin, Ann J, Beck, Justine, Sise, Thucuma, Kapogiannis, Bill G, George, Kathleen, Morgan, Patricia, Woolwine-Cunningham, Yvonne, Leblanc, Rebecca, Trabert, Kathleen, Mendell, Jeanne, Alvero, Carmelita, Farhad, Mona, Pasyar, Sarah, Muresan, Petronella, Patel, Nehali, English, Adrienne, Heince, Ryan, Jones, Sandra, Cooper, Ellen, McLaud, Debra, McFarland, Elizabeth, Hays, Shane Curran, Dunn, Jennifer, Navarro, Kacey, Robson, Amanda, Ndiwani, Hilda, Mathiba, Ruth, Ramsagar, Nastassja, Chotirosniramit, Nuntisa, Khamrong, Chintana, Chantong, Jiraporn, Srita, Angkana, Cressey, Tim R, Sukrakanchana, Praornsuda, Kaewmamuang, Kanyanee, Thaweesombat, Yupawan, Vanprapar, Nirun, Chokephaibulkit, Kulkanya, Kongstan, Nantaka, and Lermankul, Watcharee

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, HIV/AIDS, Infectious Diseases, Clinical Trials and Supportive Activities, Clinical Research, Pediatric, Sexually Transmitted Infections, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adolescent, Female, Humans, Male, Anti-HIV Agents, Anti-Retroviral Agents, HIV Infections, HIV Seropositivity, Lamivudine, RNA, Tenofovir, Treatment Outcome, adolescents, doravirine, HIV-1, MK-1439A, IMPAACT 2014 study team, Medical microbiology, Paediatrics
Abstract

BackgroundIMPAACT 2014 study is a phase I/II, multicenter, open-label, nonrandomized study of doravirine (DOR) co-formulated with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) as fixed-dose combination (DOR FDC) in adolescents with HIV-1. We report the efficacy, safety, and tolerability of DOR FDC through 96 weeks.MethodsParticipants were adolescents aged 12 to

Published
2023

2. Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial

Author

Chinula, Lameck, Ziemba, Lauren, Brummel, Sean, McCarthy, Katie, Coletti, Anne, Krotje, Chelsea, Johnston, Benjamin, Knowles, Kevin, Moyo, Sikhulile, Stranix-Chibanda, Lynda, Hoffman, Risa, Sax, Paul E, Stringer, Jeffrey, Chakhtoura, Nahida, Jean-Philippe, Patrick, Korutaro, Violet, Cassim, Haseena, Fairlie, Lee, Masheto, Gaerolwe, Boyce, Ceejay, Frenkel, Lisa M, Amico, K Rivet, Purdue, Lynette, Shapiro, Roger, Mmbaga, Blandina Theophil, Patel, Faeezah, van Wyk, Jean, Rooney, James F, Currier, Judith S, Lockman, Shahin, Best, Brookie M, Blanchette, Cheryl D, Browning, Renee, Jaliaah, Nagawa, Mirochnick, Mark, Murtaugh, William A, Patras, Emmanuel, Whalen, Frances, Momper, Jeremiah D, Ponatshego, Ponego L, Tirelo, Lesedi, Seme, Boitshepo J, Modise, Georginah O, Raesi, Mpho S, Budu, Marian E, Ramogodiri, Moakanyi, Oliveira, Ricardo H, Hofe, Cristina B, de Abreu, Thalita Fernandes, Pestanha, Lorena M, João, Esaú, Sidi, Leon C, Fuller, Trevon, Cruz, Maria LS, Pinto, Jorge, Ferreira, Flãvia, Correa, Mãrio, Romeiro, Juliana, Pilotto, Jose H, Fernandes, Luis EBC, Moreira, Luiz F, Gomes, Ivete M, Naik, Shilpa, Nevrekar, Neetal, Mave, Vidya, Kinikar, Aarti, Horne, Elizea, Soma-Kasiram, Hamisha, Violari, Avy, Mathiba, Sisinyana R, Nyati, Mandisa, Theron, Gerhard, de Jager, Jeanne, Rossouw, Magdel, Rossouw, Lindie, Hanley, Sherika, Desmond, Alicia C, Gazu, Rosemary, Govender, Vani, Chalermchockcharoenkit, Amphan, Thamkhantho, Manopchai, Werarak, Peerawong, Rungmaitree, Supattra, Achalapong, Jullapong, Sitiritkawin, Lukkana, Cressey, Tim R, Sukrakanchana, Pra-ornsuda, Aurpibul, Linda, Tongprasert, Fuanglada, Khamrong, Chintana, Kiattivej, Sopida, Wabwire, Deo, Kabugo, Enid, Maena, Joel, Nakayiwa, Frances, Ndyanabangi, Victoria, Nagaddya, Beatrice, Sekabira, Rogers, Ashaba, Justus, and Mitchell, Charles D

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Women's Health, Sexually Transmitted Infections, HIV/AIDS, Pediatric, Clinical Trials and Supportive Activities, Clinical Research, Infectious Diseases, Maternal Health, Pregnancy, 6.1 Pharmaceuticals, Infection, Reproductive health and childbirth, Good Health and Well Being, Child, Female, Humans, Male, HIV Infections, Anti-HIV Agents, Tenofovir, Benzoxazines, Emtricitabine, Adenine, RNA, Viral Load, IMPAACT 2010/VESTED Study Team and Investigators, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundDrugs taken during pregnancy can affect maternal and child health outcomes, but few studies have compared the safety and virological efficacy of different antiretroviral therapy (ART) regimens. We report the primary safety outcomes from enrolment up to 50 weeks post partum and a secondary virological efficacy outcome at 50 weeks post partum of three commonly used ART regimens for HIV-1.MethodsIn this multicentre, open-label, randomised, controlled, phase 3 trial, we enrolled pregnant women aged 18 years or older with confirmed HIV-1 infection at 14-28 weeks of gestation. Women were enrolled at 22 clinical research sites in nine countries (Botswana, Brazil, India, South Africa, Tanzania, Thailand, Uganda, the USA, and Zimbabwe). Participants were randomly assigned (1:1:1) to one of three oral regimens: dolutegravir, emtricitabine, and tenofovir alafenamide; dolutegravir, emtricitabine, and tenofovir disoproxil fumarate; or efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Up to 14 days of antepartum ART before enrolment was permitted. Women with known multiple gestation, fetal anomalies, acute significant illness, transaminases more than 2·5 times the upper limit of normal, or estimated creatinine clearance of less than 60 mL/min were excluded. Primary safety analyses were pairwise comparisons between ART regimens of the proportion of maternal and infant adverse events of grade 3 or higher up to 50 weeks post partum. Secondary efficacy analyses at 50 weeks post partum included a comparison of the proportion of women with plasma HIV-1 RNA of less than 200 copies per mL in the combined dolutegravir-containing groups versus the efavirenz-containing group. Analyses were done in the intention-to-treat population, which included all randomly assigned participants with available data. This trial was registered with ClinicalTrials.gov, NCT03048422.FindingsBetween Jan 19, 2018, and Feb 8, 2019, we randomly assigned 643 pregnant women to the dolutegravir, emtricitabine, and tenofovir alafenamide group (n=217), the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group (n=215), and the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (n=211). At enrolment, median gestational age was 21·9 weeks (IQR 18·3-25·3), median CD4 count was 466 cells per μL (308-624), and median HIV-1 RNA was 903 copies per mL (152-5183). 607 (94%) women and 566 (92%) of 617 liveborn infants completed the study. Up to the week 50 post-partum visit, the estimated probability of experiencing an adverse event of grade 3 or higher was 25% in the dolutegravir, emtricitabine, and tenofovir alafenamide group; 31% in the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group; and 28% in the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (no significant difference between groups). Among infants, the estimated probability of experiencing at least one adverse event of grade 3 or higher by postnatal week 50 was 28% overall, with small and non-statistically significant differences between groups. By postnatal week 50, 14 infants whose mothers were in the efavirenz-containing group (7%) died, compared with six in the combined dolutegravir groups (1%). 573 (89%) women had HIV-1 RNA data available at 50 weeks post partum: 366 (96%) in the dolutegravir-containing groups and 186 (96%) in the efavirenz-containing group had HIV-1 RNA less than 200 copies per mL, with no significant difference between groups.InterpretationSafety and efficacy data during pregnancy and up to 50 weeks post partum support the current recommendation of dolutegravir-based ART (particularly in combination with emtricitabine and tenofovir alafenamide) rather than efavirenz, emtricitabine, and tenofovir disoproxil fumarate, when started in pregnancy.FundingNational Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health.

Published
2023

3. Pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir dispersible tablets in infants and children with HIV-1 (IMPAACT P1093): results of an open-label, phase 1–2 trial

Author

Ruel, Theodore D, Acosta, Edward P, Liu, Jessica P, Gray, Kathryn P, George, Kathleen, Montañez, Nicole, Popson, Stephanie, Buchanan, Ann M, Bartlett, Mattie, Dayton, Dale, Anthony, Patricia, Brothers, Cynthia, Vavro, Cynthia, Singh, Rajendra, Koech, Lucy, Vhembo, Tichaona, Mmbaga, Blandina T, Pinto, Jorge A, Dobbels, Els FM, Archary, Moherndran, Chokephaibulkit, Kulkanya, Ounchanum, Pradthana, Deville, Jaime G, Hazra, Rohan, Townley, Ellen, Wiznia, Andrew, team, IMPAACT P1093, Carter, Michele F, Mansky, Hannah, Ferreira, Flavia F, Romeiro, Juliana, D'Angelo, Jessica, Williams, Ruth, Jundi, Fernanda, Cruz, Maria Letícia Santos, Sidi, Claude Leon, Kataike, Hajira, Owor, Maxensia, Ahimbisibwe, Grace Miriam, van Rensburg, Anita Janse, Andrea, Catherine V, Ponatshego, Ponego L, Budu, Marian, Tirelo, Lesedi, Masheto, Gaerolwe R, Raesi, Mpho S, Ramogodiri, Moakanyi, Chanthong, Jiraporn, Khamrong, Chintana, Aurpibul, Linda, Fairlie, Lee, Patel, Faeezah, Soma-Kashiram, Hamisha, Hanley, Sherika, Govender, Vani, Sturzbecher, Fernanda Tomé, Cervi, Maria Célia, Njau, Boniface, Matibe, Petronilla, Mukonowenzou, Ruvimbo, Marozva, Catherine C, Keter, Winnie C, Bii, Priscilla C, Cressey, Tim R, Sukrakanchana, Pra-ornsuda, Rungmaitree, Supattra, Pilotto, Jose Henrique, Fernandes, Luis Eduardo, and Gomes, Ivete Martins

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Pediatric, Sexually Transmitted Infections, HIV/AIDS, Prevention, Clinical Trials and Supportive Activities, Women's Health, Clinical Research, Pediatric AIDS, Infectious Diseases, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Infection, Good Health and Well Being, Adolescent, Adult, Antiviral Agents, Child, Child, Preschool, Female, HIV Infections, HIV Integrase Inhibitors, HIV Seropositivity, HIV-1, Heterocyclic Compounds, 3-Ring, Humans, Infant, Male, Oxazines, Piperazines, Pyridones, RNA, Tablets, IMPAACT P1093 team, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundSafe and potent antiretroviral medications in child-friendly formulations are needed to treat young children living with HIV-1. We aimed to select dosing for a dispersible tablet formulation of dolutegravir that achieved pharmacokinetic exposures similar to those in adults, and was safe and well tolerated in young children.MethodsInternational Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) P1093 is a phase 1-2 ongoing multicentre, open-label, non-comparative study of dolutegravir. A 5 mg dispersible tablet formulation of dolutegravir was studied in children aged 4 weeks to less than 6 years old, weighing at least 3 kg, with HIV RNA of greater than 1000 copies per mL and no previous treatment with integrase strand transfer inhibitor recruited from IMPAACT clinical research sites in Africa, the Americas, and Asia. Doses were selected on the basis of intensive pharmacokinetic evaluation on days 5-10, with safety and tolerability assessed up to 48 weeks. The primary objectives of this study are to evaluate the pharmacokinetics of dolutegravir in combination with optimised background therapy and to establish the dose of dolutegravir that achieves the targeted 24-h trough concentration and 24-h area under the curve for infants, children, and adolescents with HIV-1, to establish the safety and tolerability of dolutegravir at 24 and 48 weeks, and to select a dose that achieves similar exposure to the dolutegravir 50 mg once daily dose in adults. This analysis included participants treated with the proposed dose of dolutegravir dispersible tablets in two stages for each of three age cohorts. This trial is registered at ClinicalTrials.gov (NCT01302847) and is ongoing.FindingsWe recruited 181 participants from April 20, 2011, to Feb 19, 2020; of these, 96 received dolutegravir dispersible tablets. This analysis included 73 (35, 48% female) participants who received the final proposed dose with median (range) age of 1 year (0·1 to 6·0), weight (minimum-maximum) of 8·5 kg (3·7 to 18·5), plasma HIV-1 RNA concentration of 4·2 log10 copies per mL (2·1 to 7·0), and CD4% of 24·0% (0·3 to 49·0); 64 (87·7%) were treatment-experienced. The selected dose within each age cohort (≥2 years to

Published
2022

4. Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial

Author

Best, Brookie M., Blanchette, Cheryl D, Browning, Renee, Jaliaah, Nagawa, Mirochnick, Mark, Murtaugh, William A., Patras, Emmanuel, Whalen, Frances, Momper, Jeremiah D., Ponatshego, Ponego L., Tirelo, Lesedi, Seme, Boitshepo J., Modise, Georginah O., Raesi, Mpho S., Budu, Marian E., Ramogodiri, Moakanyi, Oliveira, Ricardo H., Hofe, Cristina B, Fernandes de Abreu, Thalita, Pestanha, Lorena M., João, Esaú, Sidi, Leon C., Fuller, Trevon, Cruz, Maria L.S, Pinto, Jorge, Ferreira, Flãvia, Correa Jr, Mãrio, Romeiro, Juliana, Pilotto, Jose H., Fernandes, Luis E.B.C, Moreira, Luiz F., Gomes, Ivete M., Naik, Shilpa, Nevrekar, Neetal, Mave, Vidya, Kinikar, Aarti, Horne, Elizea, Soma-Kasiram, Hamisha, Violari, Avy, Mathiba, Sisinyana R., Nyati, Mandisa, Theron, Gerhard, de Jager, Jeanne, Rossouw, Magdel, Rossouw, Lindie, Hanley, Sherika, Desmond, Alicia C., Gazu, Rosemary, Govender, Vani, Chalermchockcharoenkit, Amphan, Thamkhantho, Manopchai, Werarak, Peerawong, Rungmaitree, Supattra, Achalapong, Jullapong, Sitiritkawin, Lukkana, Cressey, Tim R., Sukrakanchana, Pra-ornsuda, Aurpibul, Linda, Tongprasert, Fuanglada, Khamrong, Chintana, Kiattivej, Sopida, Wabwire, Deo, Kabugo, Enid, Maena, Joel, Nakayiwa, Frances, Ndyanabangi, Victoria, Nagaddya, Beatrice, Sekabira, Rogers, Ashaba, Justus, Mitchell, Charles D., Drada, Adriana, Alvarez, Grace A., Scott, Gwendolyn B., Rathore, Mobeen, Mahmoudi, Saniyyah, Shabbir, Adnan, Maraqa, Nizar, Mandima, Patricia F., Mutambanengwe, Mercy, Maonera, Suzen, Chareka, Gift, Nematadzira, Teacler, Chanaiwa, Vongai, Matubu, Taguma A., Tamirepi, Kevin, Maturure, Sukunena, Mhembere, Tsungai, Vhembo, Tichaona, Chidemo, Tinashe, Chinula, Lameck, Ziemba, Lauren, Brummel, Sean, McCarthy, Katie, Coletti, Anne, Krotje, Chelsea, Johnston, Benjamin, Knowles, Kevin, Moyo, Sikhulile, Stranix-Chibanda, Lynda, Hoffman, Risa, Sax, Paul E, Stringer, Jeffrey, Chakhtoura, Nahida, Jean-Philippe, Patrick, Korutaro, Violet, Cassim, Haseena, Fairlie, Lee, Masheto, Gaerolwe, Boyce, Ceejay, Frenkel, Lisa M, Amico, K Rivet, Purdue, Lynette, Shapiro, Roger, Mmbaga, Blandina Theophil, Patel, Faeezah, van Wyk, Jean, Rooney, James F, Currier, Judith S, and Lockman, Shahin

Published
2023
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5. Pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir dispersible tablets in infants and children with HIV-1 (IMPAACT P1093): results of an open-label, phase 1–2 trial

Author

Deville, Jaime G, Carter, Michele F, Mansky, Hannah, Pinto, Jorge A, Ferreira, Flavia F, Romeiro, Juliana, D'Angelo, Jessica, Williams, Ruth, Jundi, Fernanda, Cruz, Maria Letícia Santos, Sidi, Claude Leon, Kataike, Hajira, Owor, Maxensia, Ahimbisibwe, Grace Miriam, van Rensburg, Ms Anita Janse, Andrea, Catherine V, Ponatshego, Ponego L, Budu, Marian, Tirelo, Lesedi, Masheto, Gaerolwe R, Raesi, Mpho S., Ramogodiri, Moakanyi, Chanthong, Jiraporn, Khamrong, Chintana, Aurpibul, Linda, Fairlie, Lee, Patel, Faeezah, Soma-Kashiram, Hamisha, Archary, Moherndran, Hanley, Sherika, Govender, Vani, Sturzbecher, Fernanda Tomé, Cervi, Maria Célia, Mmbaga, Blandina T, Njau, Boniface, Matibe, Petronilla, Mukonowenzou, Ruvimbo, Marozva, Catherine C, Keter, Winnie C, Bii, Priscilla C, Ounchanum, Pradthana, Cressey, Tim R, Sukrakanchana, Pra-ornsuda, Chokephaibulkit, Kulkanya, Rungmaitree, Supattra, Pilotto, Jose Henrique, Fernandes, Luis Eduardo, Gomes, Ivete Martins, Ruel, Theodore D, Acosta, Edward P, Liu, Jessica P, Gray, Kathryn P, George, Kathleen, Montañez, Nicole, Popson, Stephanie, Buchanan, Ann M, Bartlett, Mattie, Dayton, Dale, Anthony, Patricia, Brothers, Cynthia, Vavro, Cynthia, Singh, Rajendra, Koech, Lucy, Vhembo, Tichaona, Dobbels, Els F M, Hazra, Rohan, Townley, Ellen, and Wiznia, Andrew

Published
2022
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