P1077BF: Breastfeeding 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/NCT01061151?term=PROMISE&rank=3

IRB#:

NA_00038384

Coordinator:

Nishi Suryavanshi

Enrollment:

Closed

Trial Period:

Completed

1077BF 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 three 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 prevention of postpartum transmission in breastfeeding (BF) infants?
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 1077BF) is intended for those sites where the standard method of infant feeding is breastfeeding.

Antepartum component - Pregnant HIV-infected women who intend to breastfeed and their infants.

Late Presenters - Late presenters can be identified in early or active labor or in the immediate postpartum period (up to 5 days postpartum); those who are planning to breastfeed and are potentially interested in enrolling in the Postpartum Component will be considered for registration as a late presenter.

Postpartum component - Consenting, eligible mother-infant pairs from the Antepartum Component who plan to breastfeed; and consenting, eligible mother-infant pairs from the Late Presenter Registration who plan to breastfeed (women not randomized in the Antepartum Component, who did not receive any ARVs prior to labor and delivery and were identified during labor or immediately postpartum).

Maternal Health Component - The study population will include consenting, eligible HIV-infected women with a CD4 count of > 350 cells/mm3 who were either a) randomized to triple ARV prophylaxis in the Postpartum Component and have ceased BF, reached 18 months postpartum or have confirmed infant HIV infection (in all infants if multiple births) - whichever comes first, or b) randomized to a triple ARV prophylaxis arm in the Antepartum Component but ineligible for the Postpartum Component.

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