drugset / Trial / NCT03088410
Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana
Phase 4
Completed
495 enrolled
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to assess the early longitudinal metabolic effects including insulin sensitivity in HIV-exposed uninfected (HEU) children compared to HIV-unexposed uninfected (HUU) children; as well as to determine differences in the effects of neonatal zidovudine (AZT) vs. nevirapine (NVP) prophylaxis on early longitudinal changes in insulin sensitivity in the first 3 years of life.
Timeline
- Start
- 2016-08-22
- Primary completion
- 2022-03-31
- Completion
- 2022-03-31
Publications
- Background Banda FM, Powis KM, Sun S, Makhema J, Masasa G, Yee LM, Jao J. Fetal biometry following in-utero exposure to dolutegravir-based or efavirenz-based antiretroviral therapy. AIDS. 2020 Dec 1;34(15):2336-2337. doi: 10.1097/QAD.0000000000002674. No abstract available.
- Jao J, Sun S, Bonner LB, Legbedze J, Mmasa KN, Makhema J, Mmalane M, Kgole S, Masasa G, Moyo S, Gerschenson M, Mohammed T, Abrams EJ, Kurland IJ, Geffner ME, Powis KM. Lower Insulin Sensitivity in Newborns With In Utero HIV and Antiretroviral Exposure Who Are Uninfected in Botswana. J Infect Dis. 2022 Nov 28;226(11):2002-2009. doi: 10.1093/infdis/jiac416.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nevirapine | Small molecule | — | — |
| Comparator | Zidovudine | Small molecule | — | — |