Study Details
To determine the efficacy and safety of two antiretroviral regimens (zidovudine (ZDV) and nevirapine (NVP) vs. (ZDV), lamivudine (3TC) and nelfinavir (NFV)) compared to standard ZDV regimen administered to neonates born to mothers identified as HIV-1 infected in the peripartum period for the prevention of vertical HIV-1 transmission
A Phase III, 3 arm, open-label, randomized controlled trial.
Neonates born to mothers identified as HIV-1 infected in the peripartum period
1,731 infants
Approximately 30 months total. Enrollment will take place over a period of 24-36 months. Neonates will be followed for 6 months.
Neonates who meet the eligibility criteria will be randomized to receive one of three antiretroviral regimens initiated within 48 hours of birth: ZDV + NVP or ZDV + 3TC + NFV or the standard ZDV regimen
To determine the efficacy at 4 to 6 weeks of two neonatal antiretroviral regimens (zidovudine and nevirapine and zidovudine, lamivudine and nelfinavir) compared to standard zidovudine regimen in preventing vertical HIV-1 transmission in neonates born to mothers identified as HIV-1 infected in the peripartum period.
To evaluate the safety and tolerance of the three proposed antiretroviral regimens for neonates through 6 months of age.
To compare in the three arms the rates of HIV-1 infection at birth, 7 to 10 days, and 3 months in neonates.
To evaluate the acceptability of rapid HIV testing of mothers in the peripartum period.
To evaluate the implementation and adherence to the proposed neonatal antiretroviral regimens.
To determine the pharmacokinetics of NFV, NVP, and 3TC.
To determine the virologic response to antiretrovirals and the immunologic response to early treated HIV infections in infants.
To assess the rate of genotypic and phenotypic resistance mutations to the proposed antiretrovirals among HIV-infected infants treated with antiretrovirals.