P1077FF: Formula Feeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Study Location:

India

Topic:

HIVMaternal-Child Health and HIV

Clinicaltrials.gov Link:

https://clinicaltrials.gov/ct2/show/NCT01253538?term=PROMISE&rank=1

IRB#:

NA_00049859

Coordinator:

Nishi Suryavanshi

Enrollment:

Closed

Trial Period:

Completed

1077FF is a randomized strategy trial, which is part of the PROMISE studies (1077BF, 1077FF, P1084s, and 1077HS). The Promoting Maternal and Infant Survival Everywhere (PROMISE) Protocol is a research protocol of the IMPAACT network designed to address in an integrated and comprehensive fashion critical questions currently facing HIV-infected pregnant and postpartum women and their infants:

What is the optimal intervention for the prevention of antepartum and intrapartum transmission of HIV?
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)?

This version of the PROMISE protocol (IMPAACT 1077FF) is intended for those sites where the standard method of infant feeding is formula feeding.

Antepartum Component – HIV-infected pregnant women who intend to formula feed (FF) (with and without HBV) with documented CD4 cell count > 350 cells/mm3 at screening, enrolled from 14 weeks gestation forward and prior to the onset of labor, who are ARV-naïve except for ARVs given for prior PMTCT in previous pregnancies, and their infants.

Maternal Health Component - The study population will include consenting, eligible HIV-infected women with a CD4 count of ≥ 350 cells/mm3 who were randomized to triple ARV prophylaxis in the Antepartum Component and who are formula-feeding their infants. Another comparison group will be women who did not receive triple ARV prophylaxis during pregnancy (i.e., women randomized to Antepartum ZDV + sdNVP + TRV tail) and who are formula-feeding their infants.

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