Status:
COMPLETED
Maternal TDF and FTC to Reduce NNRTI Resistance Mutations After Intrapartum NVP
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Elizabeth Glaser Pediatric AIDS Foundation
Conditions:
HIV
Pregnancy
Eligibility:
FEMALE
16+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the addition of tenofovir (TDF) and emtricitabine (FTC)to a standard PMTCT regimen containing single-dose nevirapine (NVP) can reduce the development ...
Detailed Description
Single-dose intrapartum and neonatal nevirapine (NVP), either alone or in combination with short course zidovudine (ZDV) is in widespread use to prevent mother-to-child HIV transmission throughout the...
Eligibility Criteria
Inclusion
- Serologically confirmed HIV infection;
- Gestational age of 28 to 38 weeks;
- Previous selection of a NVP-based PMTCT regimen (with or without ZDV)
- Willingness to participate in a randomized trial;
- Willingness to follow up in a postpartum visit schedule;
- Willingness to allow her infant to participate in this trial;
Exclusion
- Use of antiretroviral medications before this pregnancy, even in a single dose.
- Current use of antiretroviral medications for treatment of advanced HIV disease and/or AIDS
- Illness or complication of pregnancy likely to warrant transfer to the University Teaching Hospital (UTH), known at time of randomization;
- Known or suspected allergy to NVP or other benzodiazepine medications;
- History of known liver disease.
- Hemoglobin level of 7.9 g/dL or less
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00204308
Start Date
March 1 2005
End Date
May 1 2007
Last Update
May 31 2012
Active Locations (2)
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1
Kalingalinga Health Centre
Lusaka, Zambia
2
Kanyama Health Centre
Lusaka, Zambia