Safety and Trough Concentrations of Nevirapine Prophylaxis Given Daily, Twice Weekly, or Weekly in Breast-Feeding Infants from Birth to 6 Months

Sponsor: US National Institutes of Health (NIH)

Protocol Summary: HIVNET 023 was a phase I/II, open-label, randomized trial of the safety and trough concentrations of three dosing regimens of nevirapine given as prophylaxis from birth to 24 weeks in breast-feeding infants born to HIV-1–infected mothers. Pregnant women were offered HIV-1 testing to screen for the study. Eligible HIV-1–infected women were enrolled in the study at 30 to 38 weeks of gestation. All women received standardized information based on the current UNAIDS guidelines on breast-feeding. Each enrolled HIV-1–infected pregnant woman was prescribed a single 200-mg oral dose of NVP to self-administer at the onset of labor.

Years: 2000 – 2001

Investigators: Avinash Shetty, MD
Yvonne Maldonado, MD

Locations: Seke North and St. Mary’s CRSs


Completed Study


Shetty AK, Coovadia HM, Mirochnick MM, Maldonado Y, Mofenson LM, et al. (2003) Safety and trough concentrations of nevirapine phrophylaxis given daily, twice daily, or weekly in breast-feeding infants from birth to 6 months. J Acquir Immune Defic Synd; 34(5): 482-90.

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