HIV Infections Clinical Trial
Official title:
A Prospective Randomised Open Label Clinical Trial to Determine the Efficacy of Nevirapine, Compared With a Combination of ZDV + 3TC, in Decreasing the Peripartum Mother to Child Transmission of HIV. Women, Who Present After 38 Weeks Gestation or in Labour After 35 Weeks Gestation and Who Are Anti-retroviral Naive, Will be Included.
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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