drugset / Trial / NCT00936195
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
Phase 3
Withdrawn
French National Agency for Research on AIDS and Viral Hepatitis
Abbott · collabGilead Sciences · collabGlaxoSmithKline · collabMerck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2010-01
- Primary completion
- 2013-01
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 600 mg | — |
| Comparator | Lamivudine | Other / unclassified | 150 mg | — |
| Comparator | Lopinavir | Other / unclassified | 200 mg | — |
| Comparator | Ritonavir | Other / unclassified | 50 mg | — |
| Comparator | Tenofovir | Small molecule | 300 mg | — |
| Comparator | Zidovudine | Small molecule | 300 mg | — |
| Comparator | emtricitabine | Other / unclassified | 200 mg | — |