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
HPTN
Completed Study
Publication:
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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