drugset / Trial / NCT01229761
Study to Improve Survival Among HIV-Exposed Infants in Botswana
Phase 2
Completed
3724 enrolled
Harvard School of Public Health (HSPH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabHarvard Medical School (HMS and HSDM) · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedFactorialQuadruple-blindPrevention
Summary
The purpose of this study is to find ways to improve infant health and survival among infants whose mothers are HIV-infected but who do not themselves have HIV.
Timeline
- Start
- 2011-05
- Primary completion
- 2015-03
- Completion
- 2018-10
Publications
- Powis KM, Souda S, Lockman S, Ajibola G, Bennett K, Leidner J, Hughes MD, Moyo S, van Widenfelt E, Jibril HB, Makhema J, Essex M, Shapiro RL. Cotrimoxazole prophylaxis was associated with enteric commensal bacterial resistance among HIV-exposed infants in a randomized controlled trial, Botswana. J Int AIDS Soc. 2017 Nov;20(3):e25021. doi: 10.1002/jia2.25021.
- Lockman S, Hughes M, Powis K, Ajibola G, Bennett K, Moyo S, van Widenfelt E, Leidner J, McIntosh K, Mazhani L, Makhema J, Essex M, Shapiro R. Effect of co-trimoxazole on mortality in HIV-exposed but uninfected children in Botswana (the Mpepu Study): a double-blind, randomised, placebo-controlled trial. Lancet Glob Health. 2017 May;5(5):e491-e500. doi: 10.1016/S2214-109X(17)30143-2.
- Ajibola G, Zash R, Shapiro RL, Batlang O, Botebele K, Bennett K, Chilisa F, Widenfelt EV, Makhema J, Lockman S, Holmes LB, Powis KM. Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana. PLoS One. 2017 Mar 24;12(3):e0173800. doi: 10.1371/journal.pone.0173800. eCollection 2017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | trimethoprim-sulfamethoxazole | Unknown | 200 mg | — |