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Tenofovir/Emtricitabine for PMTCT in Africa and Asia (ANRS 12109 TEmAA)

NCT00334256 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2011-12-05

No results posted yet for this study

Summary

To study the pharmacokinetic properties, safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their newborns, with a view to prevention of mother-to-child transmission (PMTCT) of HIV-1 in Africa and Asia.

Conditions

  • HIV Infection
  • Pregnancy

Interventions

DRUG

Tenofovir (TDF)

DRUG

Emtricitabine (FTC)

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Gilead Sciences

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • François Dabis, MD, PhD · Université Bordeaux 2

  • Didier K Ekouevi, MD, PhD · Programme PACCI Abidjan

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-07-31
Completion
2009-12-31

Countries

  • Cambodia
  • Côte d’Ivoire
  • South Africa

Study Locations

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Entities

Companies

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 NCT00334256 on ClinicalTrials.gov