At a glance
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Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World
In Brief
An observational study for HIV Infections. Completed, enrolled 236 participants across 23 sites in 8 countries.
Detailed Summary
In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women. Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.