Assessment of Safety and Toxicity among Infants Born To HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World

Sponsor: US National Institute of Allergy and Infectious Diseases (NIAID)

Protocol Summary: A5190-P1054 was a prospective, observational, cohort study of infants born to HIV-1-infected women while enrolled in NIH-sponsored, international, antiretroviral (ARV) treatment protocols. These infants will be enrolled and followed prospectively to describe the safety, toxicity, and potential side effects of in utero and breast milk exposure to the ARV drugs used in international treatment protocols.

Years: 2006 – 2008

Investigator: James Hakim, MBChB, FRCP

Location: Parirenyatwa CRS


Completed Study


Nielsen-Saines K, Komarow L, Cu-Uvin S, Jourdain G, Klingman KL, et al. (2012) Infant outcomes after maternal antiretroviral exposure in resource-limited settings. Pediatrics 219(6): e1525-32.

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