Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this study was to examine, in an integrated and comprehensive fashion, three
critical questions currently facing HIV-infected pregnant and postpartum women and their
infants:
1. What is the optimal intervention for the prevention of antepartum and intrapartum
transmission of HIV?
2. What is the optimal intervention for the prevention of postpartum transmission in
breastfeeding (BF) infants?
3. What is the optimal intervention for the preservation of maternal health after the risk
period for prevention of mother-to-child-transmission ends (either at delivery or
cessation of BF)?
The overall PROMISE protocol had three separate interventional components to address each of
these three questions and was conducted at locations in Africa and other parts of the world.
Due to variations in the standard of care for HIV-infected pregnant and postpartum women and
their infants at different sites, not all of these questions were relevant. Therefore, two
separate versions of the PROMISE protocol were developed, each containing only the relevant
components. The 1077BF protocol was used at sites where the standard method of infant feeding
was breastfeeding, whereas the 1077FF protocol was used at sites where the standard method of
infant feeding was formula feeding. The analyses were collapsed across the two protocol
versions, and therefore the summaries contain the results of the 1077BF and/or the 1077FF
protocols.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lamivudine Lamivudine, zidovudine drug combination Lopinavir Nevirapine Ritonavir Tenofovir Zidovudine