Maternal TDF and FTC to Reduce NNRTI Resistance Mutations After Intrapartum NVP

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: Female

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 of post-ingestion HIV resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Elizabeth Glaser Pediatric AIDS Foundation
• Treatments: Emtricitabine; Nevirapine; Reverse Transcriptase Inhibitors; Tenofovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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