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

• Status: Withdrawn
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Abbott; Gilead Sciences; GlaxoSmithKline; Merck Sharp & Dohme Corp.
• Treatments: Efavirenz; Emtricitabine; Lamivudine; Lamivudine, zidovudine drug combination; Lopinavir; Ritonavir; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.