- To assess the effectiveness of the addition of a single dose of nevirapine (NVP) to Zidovudine (ZDV, also known as AZT), in reducing transmission of HIV-1 from mother to child. To determine if maternal NVP (per HIVNET 012 protocol) is necessary in the setting of maternal ZDV from 34 weeks gestation through delivery AND single-dose prophylactic infant NVP at birth plus ZDV from birth to 4 weeks for the reduction of transmission of HIV-1 from mother to child.
- To assess the effect of prophylactic AZT given to infants during breast feeding on HIV transmission.
- To confirm the safety and tolerance of one dose of NVP given to mothers and infants.
- To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age.
- To determine the association between assigned infant feeding strategy and maternal morbidity and mortality.
- To determine the rates of virologic response to NNRTI-containing HAART at 26 and 52 weeks after initiating treatment, among HIV+ women who previously received single dose NVP versus placebo during labour.
Study Design: A 2 x 2 factorial randomized clinical trial with peripartum (single-dose nevirapine vs placebo) and postpartum infant feeding (formula vs breastfeeding with infant zidovudine prophylaxis) interventions.
Study Population: Pregnant women living with HIV and their newborns
Study Duration: 2.5 years
Sponsor: - Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Breastfeeding with zidovudine prophylaxis was not as effective as formula feeding in preventing postnatal HIV transmission, but was associated with a lower mortality rate at 7 months. Both strategies had comparable HIV-free survival at 18 months.