Effects of HIV and ARV Exposure on Child Health and Neurodevelopment, Botswana (“Tshipidi”)

Study Objectives: to determine if HIV-exposed uninfected (HEU) children had worse neurodevelopmental outcomes at 24 months compared with HIV-unexposed uninfected (HUU) children in Botswana

Study Design: Prospective observational study

Study Population: HIV-infected and –uninfected mothers and their toddlers

Study Duration: 2 years

Sponsor: National Institute of Mental Health (NIMH).

Randomized Trial of LPV/r/ZDV3TC vs. ABC/ZDV/3TC to Prevent MTCT in Pregnant/Breastfeeding Women with CD4>200 (“MmaBana”)

Study Objectives: To determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.

Study Design: Randomized clinical trial

Study Population: Pregnant women living with HIV and their infants

Study Duration: 24 months

Virologic Response to NVP-Containing HAART after Single-DoseNVP vs.Placebo (“Mashi Plus”)

Study Objectives: To assess the virologic responses of women and infants to nevirapine-based antiretroviral treatment after previous exposure to a single dose of nevirapine or placebo in the setting of a short course of zidovudine.

Study Design: prospective observational study nested within a randomized clinical trial

Study Population: Postpartum women living with HIV

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

A Randomized Study of Cotrimoxazole Prophylaxis and Longer Breastfeeding Duration to Improve Survival Among HIV-Exposed Infants in Botswana ("Mpepu")

Study Objectives

  • Primary: To determine whether cotrimoxazole offers a survival benefit for HIV-exposed uninfected children
  • Secondary: To evaluate the effect of breastfeeding duration on child mortality

Study Design: Double-blind, randomized, placebo-controlled trial

Study Population: Women living with HIV, age ≥18 years, >26 weeks gestation and < 34 days postpartum, and their infants

Study Duration: 4 years

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