Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 3,300
- Locations
- 1
- Primary Endpoint
- A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks.
Study Overview
Brief Summary
The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.
Detailed Description
This is a three-arm randomized, open label, clinical trial to evaluate the effectiveness of two extended regimens of antiretrovirals compared to infant single dose nevirapine plus AZT given twice daily for 1 week (comparison regimen). All infants receive the comparison regimen at birth and then randomized at birth to start either one of the two extended regimens after the first week. The extended regimens are nevirapine daily and nevirapine plus AZT daily - both regimens are given up to age 14 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 54 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Had given birth within the last 24 hours
- •Ability and willingness to give informed consent for HIV testing and enrollment into the study
- •Willing to receive HIV results
- •HIV infected
- •Planning to deliver or had given birth at the study clinics
- •Willing to come back for follow-up visits for 2 years postnatally
- •Resident of Blantyre city or its suburbs
Exclusion Criteria
- •HIV negative
- •Women with discordant HIV results
- •Women who indicate that they will not breastfeed at time of delivery
- •Inability or unwillingness to follow any of the inclusion requirements
- •Newborn with life-threatening condition
- •Women who previously enrolled in this study and have a second pregnancy cannot reenroll
Arms & Interventions
A
Single dose NVP + ZDV daily for the first week.
Intervention: Nevirapine (Drug)
A
Single dose NVP + ZDV daily for the first week.
Intervention: AZT (Drug)
A
Single dose NVP + ZDV daily for the first week.
Intervention: NVP and AZT (Drug)
C
Arm A plus NVP + ZDV daily to age 14 weeks.
Intervention: Nevirapine (Drug)
C
Arm A plus NVP + ZDV daily to age 14 weeks.
Intervention: AZT (Drug)
C
Arm A plus NVP + ZDV daily to age 14 weeks.
Intervention: NVP+AZT (Drug)
B
Arm A plus oral NVP daily to age 14 weeks.
Intervention: Nevirapine (Drug)
B
Arm A plus oral NVP daily to age 14 weeks.
Intervention: NVP (Drug)
Outcomes
Primary Outcomes
A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks.
Time Frame: 9 months
Secondary Outcomes
- To determine overall infant survival rates at 6, 12, 18 and 24 months.(6,12,18 & 24 months)