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Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations for HIV-1 PMTCT in Pregnant and Breastfeeding Women : a Phase 3 Trial

NCT00936195 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-02-15

No results posted yet for this study

Summary

To assess the maternal and infant safety of a single daily fixed-dose combination of TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and 3TC/ZDV (Combivir®) given to African women to prevent overall MTCT in populations practicing breastfeeding.

Conditions

  • HIV Infection
  • Pregnancy
  • Breastfeeding
  • HIV Infections

Interventions

DRUG

Efavirenz-Tenofovir-Emtricitabine

Atripla (R) : Efavirenz 600 mg - Tenofovir 300 mg - Emtricitabine 200 mg; Dosage : 1 pill/day

DRUG

Zidovudine-Lamivudine-Lopinavir/Ritonavir

Combivir (R) : Zidovudine 300 mg - Lamivudine 150 mg Dosage : 1 pill twice a day Kaletra (R) or Aluvia (R) : Lopinavir 200 mg / Ritonavir 50 mg Dosage : 2 or 3 pills twice a day

Sponsors & Collaborators

Principal Investigators

  • Didier K Ekouevi, MD, PhD · Programme PACCI Abidjan, Cote d'Ivoire

  • François Dabis, MD, PhD · Bordeaux 2 University, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-01-31
Completion
2013-06-30

Countries

  • Côte d’Ivoire
  • Zambia

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 NCT00936195 on ClinicalTrials.gov