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

NCT00204308 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2012-05-31

No results posted yet for this study

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).

Conditions

  • HIV
  • Pregnancy

Interventions

DRUG

Combination tenofovir-emtricitabine

Tenofovir disoproxil 300 mg / emtricitabine 200 mg taken as a single dose during labor

Sponsors & Collaborators

  • Elizabeth Glaser Pediatric AIDS Foundation

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jeffrey S A Stringer, MD · University of Alabama at Birmingham

  • Benjamin H Chi, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00204308 on ClinicalTrials.gov