The primary objective of the study was to evaluate the efficacy of nevirapine versus ZDV+3TC (Zidovudine + Lamivudine), when administered in labor and again at postdelivery, in reducing peripartum mother to child transmission of HIV (Human Immunodeficiency Virus). The secondary objective was to assess the overall HIV transmission rate between the 2 groups (intrauterine, intrapartum and postpartum up to 6 weeks) as well as to explore the relationship between infection and timing of maternal dose relative to birth, infant feeding method, maternal peripheral blood viral load, and other potential risk factors for transmission. Following the introduction of the second and third Amendments to the Protocol, 2 substudies were added. The objectives of these substudies were to evaluate the frequency of resistance-conferring mutations to nevirapine (Amendment 2) and to ZDV+3TC (Amendment 3); to determine whether there was a reversion of any resistant virus to the wild type; and to determine if the resistant virus was transmitted from the mother to the child.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,648
Incidence of HIV transmission from a HIV positive mother to her exposed infant during the intrapartum and early postpartum period
Time frame: Day 28, 42 and 56-84
Overall HIV transmission rate (including intrauterine, intrapartum and postpartum)
Time frame: up to 84 days
Time to infection
Time frame: up to 84 days
Relationship between infection and timing of maternal dose relative to birth
Time frame: up to 84 days
Relationship between infection and infant feeding method
Time frame: up to 84 days
Relationship between infection and maternal peripheral blood viral load
Time frame: Day 0 and 28
Relationship between infection and other potential risk factors
Time frame: up to 84 days
Number of patients with adverse events
Time frame: up to 84 days
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