Efficacy of Nevirapine Compared to ZDV + 3TC Administered in Labor and Again at Postdelivery in HIV Positive Women
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.
|HIV Infections||Drug: Nevirapine Drug: Zidovudine (ZDV) Drug: Lamivudine (3TC)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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.|
- 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 ]
|Study Start Date:||April 1999|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
Mother: two doses, Infant: one dose
|Active Comparator: Zidovudine (ZDV) + Lamivudine (3TC)||Drug: Zidovudine (ZDV) Drug: Lamivudine (3TC)|