Status:
WITHDRAWN
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
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Gilead Sciences
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
The prevention of MTCT during pregnancy and through breastfeeding exposure remains challenging to date in most resource-limited settings. Peripartum HIV transmission is already amenable to ARV interve...
Eligibility Criteria
Inclusion
- being pregnant, presenting in at least the 20th week of pregnancy and no later than 2 weeks before the expected term;
- at least 18 years of age;
- diagnosed as infected with HIV-1 only;
- not currently taking any ARV drugs;
- having not been exposed to NVP in the 6 months preceding enrolment;
- willing to breastfeed their forthcoming child;
- residing and planning to continue to reside within the predefined catchment areas until 12 months after delivery;
- being able to give informed consent for enrolment in the study;
- lacking any medical contraindication to any of the proposed ARV medications;
- and accepting the principle of being randomized to receive one of the ARV regimens evaluated within the study, to prevent MTCT and for their own health when required.
Exclusion
- presenting within 2 weeks before the expected term;
- currently taking ARV drugs;
- having been exposed to NVP in the 6 months preceding enrolment;
- not willing to breastfeed their forthcoming child;
- having severe renal insufficiency (creatin clearance \< 60ml/min);
- diagnosed as infected with HIV-2 only or dually infected HIV-1 and HIV-2;
- hemoglobin \< 7 g/dL in the month preceding inclusion
- HBs Ag positive
- Women meeting one of the three last exclusion criteria (HIV-2 infection or co-infection, hemoglobin \< 7 g/dL, HBs Ag positive) will not be randomized but will all received Atripla and be followed-up in an ancillary open cohort according the same procedures and agenda.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00936195
Start Date
January 1 2010
End Date
June 1 2013
Last Update
February 15 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Programme PAC-CI, site ANRS
Abidjan, Côte d’Ivoire
2
Center for Infectious Desease Reserach in Zambia
Lusaka, Zambia