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1. The Impact of Different CD4 Cell-Count Monitoring and Switching Strategies on Mortality in HIV-Infected African Adults on Antiretroviral Therapy: An Application of Dynamic Marginal Structural Models

Author

Ford, Deborah, Robins, James M, Petersen, Maya L, Gibb, Diana M, Gilks, Charles F, Mugyenyi, Peter, Grosskurth, Heiner, Hakim, James, Katabira, Elly, Babiker, Abdel G, Walker, A Sarah, Grosskurth, H, Munderi, P, Kabuye, G, Nsibambi, D, Kasirye, R, Zalwango, E, Nakazibwe, M, Kikaire, B, Nassuna, G, Massa, R, Fadhiru, K, Namyalo, M, Zalwango, A, Generous, L, Khauka, P, Rutikarayo, N, Nakahima, W, Mugisha, A, Todd, J, Levin, J, Muyingo, S, Ruberantwari, A, Kaleebu, P, Yirrell, D, Ndembi, N, Lyagoba, F, Hughes, P, Aber, M, Lara, A Medina, Foster, S, Amurwon, J, Wakholi, B Nyanzi, Mugyenyi, P, Kityo, C, Ssali, F, Tumukunde, D, Otim, T, Kabanda, J, Musana, H, Akao, J, Kyomugisha, H, Byamukama, A, Sabiiti, J, Komugyena, J, Wavamunno, P, Mukiibi, S, Drasiku, A, Byaruhanga, R, Labeja, O, Katundu, P, Tugume, S, Awio, P, Namazzi, A, Bakeinyaga, GT, Katabira, H, Abaine, D, Tukamushaba, J, Anywar, W, Ojiambo, W, Angweng, E, Murungi, S, Haguma, W, Atwiine, S, Kigozi, J, Latif, A, Hakim, J, Robertson, V, Reid, A, Chidziva, E, Bulaya-Tembo, R, Musoro, G, Taziwa, F, Chimbetete, C, Chakonza, L, Mawora, A, Muvirimi, C, Tinago, G, Svovanapasis, P, Simango, M, Chirema, O, Machingura, J, Mutsai, S, Phiri, M, Bafana, T, Chirara, M, Muchabaiwa, L, Muzambi, M, Katabira, E, and Ronald, A

Subjects
Clinical Research, Clinical Trials and Supportive Activities, HIV/AIDS, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Anti-Retroviral Agents, CD4 Lymphocyte Count, Female, HIV Infections, Humans, Male, Models, Statistical, Uganda, Zimbabwe, Africa, antiretroviral therapy, drug switching, dynamic marginal structural models, HIV, monitoring, DART Trial Team, Mathematical Sciences, Medical and Health Sciences, Epidemiology
Abstract

In Africa, antiretroviral therapy (ART) is delivered with limited laboratory monitoring, often none. In 2003-2004, investigators in the Development of Antiretroviral Therapy in Africa (DART) Trial randomized persons initiating ART in Uganda and Zimbabwe to either laboratory and clinical monitoring (LCM) or clinically driven monitoring (CDM). CD4 cell counts were measured every 12 weeks in both groups but were only returned to treating clinicians for management in the LCM group. Follow-up continued through 2008. In observational analyses, dynamic marginal structural models on pooled randomized groups were used to estimate survival under different monitoring-frequency and clinical/immunological switching strategies. Assumptions included no direct effect of randomized group on mortality or confounders and no unmeasured confounders which influenced treatment switch and mortality or treatment switch and time-dependent covariates. After 48 weeks of first-line ART, 2,946 individuals contributed 11,351 person-years of follow-up, 625 switches, and 179 deaths. The estimated survival probability after a further 240 weeks for post-48-week switch at the first CD4 cell count less than 100 cells/mm(3) or non-Candida World Health Organization stage 4 event (with CD4 count

Published
2015

2. High Rate of HIV Resuppression After Viral Failure on First-line Antiretroviral Therapy in the Absence of Switch to Second-line Therapy

Author

Gupta, R. K., Goodall, R. L., Ranopa, M., Kityo, C., Munderi, P., Lyagoba, F., Mugarura, L., Gilks, C. F., Kaleebu, P., Pillay, D., Grosskurth, H., Kabuye, G., Nsibambi, D., Kasirye, R., Zalwango, E., Nakazibwe, M., Kikaire, B., Nassuna, G., Massa, R., Fadhiru, K., Namyalo, M., Zalwango, A., Generous, L., Khauka, P., Rutikarayo, N., Nakahima, W., Mugisha, A., Todd, J., Levin, J., Muyingo, S., Ruberantwari, A., Yirrell, D., Ndembi, N., Hughes, P., Aber, M., Medina Lara, A., Foster, S., Amurwon, J., Mugyenyi, P., Ssali, F., Tumukunde, D., Otim, T., Kabanda, J., Musana, H., Akao, J., Kyomugisha, H., Byamukama, A., Sabiiti, J., Komugyena, J., Wavamunno, P., Mukiibi, S., Drasiku, A., Byaruhanga, R., Labeja, O., Katundu, P., Tugume, S., Awio, P., Namazzi, A., Bakeinyaga, T. G., Katabira, H., Abaine, D., Tukamushaba, J., Anywar, W., Ojiambo, W., Angweng, E., Murungi, S., Haguma, W., Atwiine, S., Kigozi, J., Latif, A., Hakim, J., Robertson, V., Reid, A., Chidziva, E., Bulaya-Tembo, R., Musoro, G., Taziwa, F., Chimbetete, C., Chakonza, L., Mawora, A., Muvirimi, C., Tinago, G., Svovanapasis, P., Simango, M., Chirema, O., Machingura, J., Mutsai, S., Phiri, M., Bafana, T., Chirara, M., Muchabaiwa, L., Muzambi, M., Katabira, E., Ronald, A., Kambungu, A., Lutwama, F., Nanfuka, A., Walusimbi, J., Nabankema, E., Nalumenya, R., Namuli, T., Kulume, R., Namata, I., Nyachwo, L., Florence, A., Kusiima, A., Lubwama, E., Nairuba, R., Oketta, F., Buluma, E., Waita, R., Ojiambo, H., Sadik, F., Wanyama, J., Nabongo, P., Ochai, R., Muhweezi, D., Gilks, C., Boocock, K., Puddephatt, C., Winogron, D., Bohannon, J., Darbyshire, J., Gibb, M. D., Burke, A., Bray, D., Babiker, A., Walker, S. A., Wilkes, H., Rauchenberger, M., Sheehan, S., Peto, L., Taylor, K., Spyer, M., Ferrier, A., Naidoo, B., Dunn, D., Goodall, R., Nanfuka, R., Mufuka-Kapuya, C., Kapaata, A., Katuramur, M., Magala, R., Magambo, B., Mataruka, K., McCormick, A., Musunga, T., Nabankkema, M., Nkalubo, J., Nkurunziza, P., Parry, C., Nyanzi Wakholi, B., Weller, I., Bahendeka, S., Bassett, M., Chogo Wapakhabulo, A., Gazzard, B., Mapuchere, C., Mugurungi, O., Burke, C., Jones, S., Newland, C., Rahim, S., Rooney, J., Smith, M., Snowden, W., Steens, J.- M., Breckenridge, A., McLaren, A., Hill, C., Matenga, J., Pozniak, A., Serwadda, D., Peto, T., Palfreeman, A., and Borok, M.

Subjects
Anti-HIV Agents, HIV, Viral Load, viral resuppression, Dideoxynucleosides, failure, resistance, Drug Combinations, Lamivudine, Africa, HIV/AIDS, Humans, Nevirapine, Viremia, Zidovudine
Abstract

In a randomized comparison of nevirapine or abacavir with zidovudine plus lamivudine, routine viral load monitoring was not performed, yet 27% of individuals with viral failure at week 48 experienced resuppression by week 96 without switching. This supports World Health Organization recommendations that suspected viral failure should trigger adherence counseling and repeat measurement before a treatment switch is considered.

Published
2013

3. Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomised non-inferiority trial

Author

DART Trial Team, Mugyenyi, P, Walker, AS, Hakim, J, Munderi, P, Gibb, DM, Kityo, C, Reid, A, Grosskurth, H, Darbyshire, JH, Ssali, F, Bray, D, Katabira, E, Babiker, AG, Gilks, CF, Kabuye, G, Nsibambi, D, Kasirye, R, Zalwango, E, Nakazibwe, M, Kikaire, B, Nassuna, G, Massa, R, Fadhiru, K, Namyalo, M, Zalwango, A, Generous, L, Khauka, P, Rutikarayo, N, Nakahima, W, Mugisha, A, Todd, J, Levin, J, Muyingo, S, Ruberantwari, A, Kaleebu, P, Yirrell, D, Ndembi, N, Lyagoba, F, Hughes, P, Aber, M, Lara, A Medina, Foster, S, Amurwon, J, Wakholi, B Nyanzi, Whitworth, J, Wangati, K, Amuron, B, Kajungu, D, Nakiyingi, J, Omony, W, Tumukunde, D, Otim, T, Kabanda, J, Musana, H, Akao, J, Kyomugisha, H, Byamukama, A, Sabiiti, J, Komugyena, J, Wavamunno, P, Mukiibi, S, Drasiku, A, Byaruhanga, R, Labeja, O, Katundu, P, Tugume, S, Awio, P, Namazzi, A, Bakeinyaga, GT, Katabira, H, Abaine, D, Tukamushaba, J, Anywar, W, Ojiambo, W, Angweng, E, Murungi, S, Haguma, W, Atwiine, S, Kigozi, J, Namale, L, Mukose, A, Mulindwa, G, Atwiine, D, Muhwezi, A, Nimwesiga, E, Barungi, G, Takubwa, J, Mwebesa, D, Kagina, G, Mulindwa, M, Ahimbisibwe, F, Mwesigwa, P, Akuma, S, Zawedde, C, Nyiraguhirwa, D, Tumusiime, C, Bagaya, L, Namara, W, Karungi, J, Kankunda, R, Enzama, R, Latif, A, Robertson, V, Chidziva, E, Bulaya-Tembo, R, Musoro, G, Taziwa, F, Chimbetete, C, Chakonza, L, Mawora, A, Muvirimi, C, Tinago, G, Svovanapasis, P, Simango, M, Chirema, O, Machingura, J, Mutsai, S, Phiri, M, Bafana, T, Chirara, M, Muchabaiwa, L, Muzambi, M, Mutowo, J, Chivhunga, T, Chigwedere, E, Pascoe, M, Warambwa, C, Zengeza, E, Mapinge, F, Makota, S, Jamu, A, Ngorima, N, Chirairo, H, Chitsungo, S, Chimanzi, J, Maweni, C, Warara, R, Matongo, M, Mudzingwa, S, Jangano, M, Moyo, K, Vere, L, Mdege, N, Machingura, I, Ronald, A, Kambungu, A, Lutwama, F, Mambule, I, Nanfuka, A, Walusimbi, J, Nabankema, E, Nalumenya, R, Namuli, T, Kulume, R, Namata, I, Nyachwo, L, Florence, A, Kusiima, A, Lubwama, E, Nairuba, R, Oketta, F, Buluma, E, Waita, R, Ojiambo, H, Sadik, F, Wanyama, J, Nabongo, P, Oyugi, J, Sematala, F, Muganzi, A, Twijukye, C, Byakwaga, H, Ochai, R, Muhweezi, D, Coutinho, A, Etukoit, B, Gilks, C, Boocock, K, Puddephatt, C, Grundy, C, Bohannon, J, Winogron, D, Burke, A, Babiker, A, Wilkes, H, Rauchenberger, M, Sheehan, S, Spencer-Drake, C, Taylor, K, Spyer, M, Ferrier, A, Naidoo, B, Dunn, D, Goodall, R, Peto, L, Nanfuka, R, Mufuka-Kapuya, C, Pillay, D, McCormick, A, Weller, I, Bahendeka, S, Bassett, M, Wapakhabulo, A Chogo, Gazzard, B, Mapuchere, C, Mugurungi, O, Burke, C, Jones, S, Newland, C, Pearce, G, Rahim, S, Rooney, J, Smith, M, Snowden, W, Steens, J-M, Breckenridge, A, McLaren, A, Hill, C, Matenga, J, Pozniak, A, Serwadda, D, Peto, T, Palfreeman, A, and Borok, M

Subjects
Male, Neutrophils, HIV Infections, law.invention, Hemoglobins, Randomized controlled trial, law, Medicine, Urea, HIV-Associated Lipodystrophy Syndrome, Hazard ratio, Lamivudine, Anemia, General Medicine, Middle Aged, Viral Load, Anti-Retroviral Agents, Creatinine, Disease Progression, RNA, Viral, Female, Drug Monitoring, Zidovudine, medicine.drug, Glomerular Filtration Rate, Adult, medicine.medical_specialty, Neutropenia, Adolescent, Organophosphonates, Acquired immunodeficiency syndrome (AIDS), Internal medicine, Fast track — Articles, Humans, Nevirapine, Adverse effect, Tenofovir, Aged, Intention-to-treat analysis, business.industry, Adenine, medicine.disease, Dideoxynucleosides, CD4 Lymphocyte Count, Clinical trial, Clinical research, Immunology, Africa, HIV-1, business
Abstract

BACKGROUND: HIV antiretroviral therapy (ART) is often managed without routine laboratory monitoring in Africa; however, the effect of this approach is unknown. This trial investigated whether routine toxicity and efficacy monitoring of HIV-infected patients receiving ART had an important long-term effect on clinical outcomes in Africa. METHODS: In this open, non-inferiority trial in three centres in Uganda and one in Zimbabwe, 3321 symptomatic, ART-naive, HIV-infected adults with CD4 counts less than 200 cells per microL starting ART were randomly assigned to laboratory and clinical monitoring (LCM; n=1659) or clinically driven monitoring (CDM; n=1662) by a computer-generated list. Haematology, biochemistry, and CD4-cell counts were done every 12 weeks. In the LCM group, results were available to clinicians; in the CDM group, results (apart from CD4-cell count) could be requested if clinically indicated and grade 4 toxicities were available. Participants switched to second-line ART after new or recurrent WHO stage 4 events in both groups, or CD4 count less than 100 cells per microL (LCM only). Co-primary endpoints were new WHO stage 4 HIV events or death, and serious adverse events. Non-inferiority was defined as the upper 95% confidence limit for the hazard ratio (HR) for new WHO stage 4 events or death being no greater than 1.18. Analyses were by intention to treat. This study is registered, number ISRCTN13968779. FINDINGS: Two participants assigned to CDM and three to LCM were excluded from analyses. 5-year survival was 87% (95% CI 85-88) in the CDM group and 90% (88-91) in the LCM group, and 122 (7%) and 112 (7%) participants, respectively, were lost to follow-up over median 4.9 years' follow-up. 459 (28%) participants receiving CDM versus 356 (21%) LCM had a new WHO stage 4 event or died (6.94 [95% CI 6.33-7.60] vs 5.24 [4.72-5.81] per 100 person-years; absolute difference 1.70 per 100 person-years [0.87-2.54]; HR 1.31 [1.14-1.51]; p=0.0001). Differences in disease progression occurred from the third year on ART, whereas higher rates of switch to second-line treatment occurred in LCM from the second year. 283 (17%) participants receiving CDM versus 260 (16%) LCM had a new serious adverse event (HR 1.12 [0.94-1.32]; p=0.19), with anaemia the most common (76 vs 61 cases). INTERPRETATION: ART can be delivered safely without routine laboratory monitoring for toxic effects, but differences in disease progression suggest a role for monitoring of CD4-cell count from the second year of ART to guide the switch to second-line treatment. FUNDING: UK Medical Research Council, the UK Department for International Development, the Rockefeller Foundation, GlaxoSmithKline, Gilead Sciences, Boehringer-Ingelheim, and Abbott Laboratories.

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4. Impact of second-line antiretroviral regimens on lipid profiles in an African setting: The DART trial sub-study

Author

Gomo, Z. A. R., Hakim, J. G., Walker, S. A., Tinago, W., Mandozana, G., Kityo, C., Munderi, P., Katabira, E., Reid, A., Gibb, D. M., Gilks, C. F., Grosskurth, H., Kabuye, G., Nsibambi, D., Kasirye, R., Zalwango, E., Nakazibwe, M., Kikaire, B., Nassuna, G., Massa, R., Fadhiru, K., Namyalo, M., Zalwango, A., Generous, L., Khauka, P., Rutikarayo, N., Nakahima, W., Mugisha, A., Todd, J., Levin, J., Muyingo, S., Ruberantwari, A., Kaleebu, P., Yirrell, D., Ndembi, N., Lyagoba, F., Hughes, P., Aber, M., Lara, A. M., Medina, A., Foster, S., Amurwon, J., Wakholi, B. N., Nyanzi, B., Wangati, K., Amuron, B., Kajungu, D., Nakiyingi, J., Omony, W., Mugyenyi, P., Ssali, F., Tumukunde, D., Otim, T., Kabanda, J., Musana, H., Akao, J., Kyomugisha, H., Byamukama, A., Sabiiti, J., Komugyena, J., Wavamunno, P., Mukiibi, S., Drasiku, A., Byaruhanga, R., Labeja, O., Katundu, P., Tugume, S., Awio, P., Namazzi, A., Bakeinyaga, G. T., Abaine, D., Tukamushaba, J., Anywar, W., Ojiambo, W., Angweng, E., Murungi, S., Haguma, W., Atwiine, S., Kigozi, J., Namale, L., Mukose, A., Mulindwa, G., Atwiine, D., Muhwezi, A., Nimwesiga, E., Barungi, G., Takubwa, J., Mwebesa, D., Kagina, G., Mulindwa, M., Ahimbisibwe, F., Mwesigwa, P., Akuma, S., Zawedde, C., Nyiraguhirwa, D., Tumusiime, C., Bagaya, L., Namara, W., Karungi, J., Kankunda, R., Enzama, R., Latif, A., Robertson, V., Chidziva, E., Bulaya-Tembo, R., Musoro, G., Taziwa, F., Chimbetete, C., Chakonza, L., Mawora, A., Muvirimi, C., Svovanapasis, P., Simango, M., Chirema, O., Machingura, J., Mutsai, S., Phiri, M., Bafana, T., Chirara, M., Muchabaiwa, L., Muzambi, M., Chigwedere, E., Pascoe, M., Warambwa, C., Zengeza, E., Mapinge, F., Makota, S., Jamu, A., Ngorima, N., Chirairo, H., Chitsungo, S., Chimanzi, J., Maweni, C., Warara, R., Matongo, M., Mudzingwa, S., Jangano, M., Moyo, K., Vere, L., Machingura, I., Ronald, A., Kambungu, A., Lutwama, F., Mambule, I., Nanfuka, A., Walusimbi, J., Nabankema, E., Nalumenya, R., Namuli, T., Kulume, R., Namata, I., Nyachwo, L., Florence, A., Kusiima, A., Lubwama, E., Nairuba, R., Oketta, F., Buluma, E., Waita, R., Ojiambo, H., Sadik, F., Wanyama, J., Nabongo, P., Oyugi, J., Sematala, F., Muganzi, A., Twijukye, C., Byakwaga, H., Ochai, R., Muhweezi, D., Coutinho, A., Etukoit, B., Boocock, K., Puddephatt, C., Grundy, C., Bohannon, J., Winogron, D., Darbyshire, J., Burke, A., Bray, D., Babiker, A., Wilkes, H., Rauchenberger, M., Sheehan, S., Spencer-Drake, C., Taylor, K., Spyer, M., Ferrier, A., Naidoo, B., Dunn, D., Ruth Goodall, Nanfuka, R., Mufuka-Kapuya, C., Pillay, D., Goodall, R., Kapaata, A., Katuramur, M., Magala, R., Magambo, B., Mataruka, K., Mccormick, A., Mugarura, L., Musunga, T., Nabankkema, M., Nkalubo, J., Nkurunziza, P., Parry, C., Weller, I., Bahendeka, S., Bassett, M., Chogo Wapakhabulo, A., Gazzard, B., Mapuchere, C., Mugurungi, O., Burke, C., Distel, M., Jones, S., Loeliger, E., Naidoo, P., Newland, C., Pearce, G., Rahim, S., Rooney, J., Smith, M., Snowden, W., Steens, J. -M, Breckenridge, A., Mclaren, A., Hill, C., Matenga, J., Pozniak, A., Serwadda, D., Peto, T., Palfreeman, A., and Borok, M.

5. Staged implementation of a two-tiered hospital-based neonatal care package in a resource-limited setting in Eastern Uganda.

Author

Burgoine K, Ikiror J, Akol S, Kakai M, Talyewoya S, Sande A, Otim T, Okello F, Hewitt-Smith A, and Olupot-Olupot P

Abstract

Neonatal mortality remains a major global challenge. Most neonatal deaths occur in low-income countries, but it is estimated that over two-thirds of these deaths could be prevented if achievable interventions are scaled up. To date, initiatives have focused on community and obstetric interventions, and there has been limited simultaneous drive to improve neonatal care in the health facilities where the sick neonates are being referred. Few data exist on the process of implementing of neonatal care packages and their impact. Evidence-based guidelines for neonatal care in health facilities in low-resource settings and direction on how to achieve these standards of neonatal care are therefore urgently needed. We used the WHO-Recommended Quality of Care Framework to build a strategy for quality improvement of neonatal care in a busy government hospital in Eastern Uganda. Twelve key interventions were designed to improve infrastructure, equipment, protocols and training to provide two levels of neonatal care. We implemented this low-cost, hospital-based neonatal care package over an 18-month period. This data-driven analysis paper illustrates how simple changes in practice, provision of basic equipment and protocols, ongoing training and dedicated neonatal staff can reduce neonatal mortality substantially even without specialist equipment. Neonatal mortality decreased from 48% to 40% (P=0.25) after level 1 care was implemented and dropped further to 21% (P<0.01) with level 2 care. In our experience, a dramatic impact on neonatal mortality can be made through modest and cost-effective interventions. We recommend that stakeholders seeking to improve neonatal care in low-resource settings adopt a similar approach., Competing Interests: Competing interests: None declared.

Published
2018
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6. Spontaneous rupture of bladder in puerperium.

Author

Wandabwa J, Otim T, and Kiondo P

Subjects
Adult, Female, Humans, Rupture, Spontaneous, Puerperal Disorders, Urinary Bladder Diseases
Abstract

Spontaneous rupture of bladder and extravasation of urine in the peritoneum without evidence of trauma is rare. This condition is an emergency. It presents in a unique way therefore, the diagnosis and treatment is usually delayed. This patient presented with an acute abdominal pain and oliguria. She had delivered normally eight days before re-admission. Investigations were done and an exploratory laparotomy was performed. There was a tear in the fundus of the bladder and the peritoneal cavity contained urine. Peritoneal lavage was done and the bladder was repaired in layers. She was put on continuous bladder drainage for three weeks followed by bladder training. The bladder resumed its normal function. Early diagnosis and appropriate management decreases the morbidity and mortality associated with this condition.

Published
2004

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