1077BF (10777): Breastfeeding Version of PROMISE Study

Study Status Study Restriction

Closed to Follow Up

Non-US

What is 1077BF?

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.

>> Read more about PROMISE study results

Study documents:

Other Study Implementation Documents

Sites where the study is implemented:

CRS ID Site Name City Country

31441

BJ Medical College CRS

Pune, Maharashtra

India

12001

University of North Carolina Lilongwe CRS

Lilongwe

Malawi

30301

College of Medicine JHU CRS

Blantyre

Malawi

8051

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

30273

George Clinic CRS

Lusaka

Zambia

30303

St. Mary's CRS (Zimbabwe)

Chitungwiza

Zimbabwe

30306

Seke North CRS (Zimbabwe)

Harare

Zimbabwe

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Chair: Mary Glenn Fowler

Study Vice-Chair: Tsungai Chipato

Study Vice-Chair: Patricia Flynn

Study Vice-Chair: James McIntyre

DAIDS Medical Officer: Renee Browning

DAIDS Medical Officer: Patrick Jean-Philippe

NICHD Medical Officer: Nahida Chakhtoura

Clinical Trials Specialist: Anne Coletti

Clinical Trials Specialist: Kathleen George

Clinical Trials Specialist: Katie McCarthy

DAIDS Clinical Representative: Judi Miller

Data Manager: Barbara Heckman

Data Manager: Linda Marillo

Drug Co. Representative: Oxana Ivanova

Drug Co. Representative: Marisol Martinez-Tristani

Drug Co. Representative: Danielle Porter

Drug Co. Representative: James Rooney

Drug Co. Representative: Wendy Snowden

Drug Co. Representative: Helen Watson

Field Representative: Linda Barlow-Mosha

ICAB Representative: Lindiwe Msweli

Investigator: Arlene Bardeguez

Investigator: Debika Bhattacharya

Investigator: Benjamin Chi

Investigator: Andrea Ciaranello

Investigator: Anna Coutsoudis

Investigator: Kenneth Freedberg

Investigator: Amita Gupta

Investigator: Risa Hoffman

Investigator: Marc Lallemant

Investigator: Elizabeth (Betsy) McFarland

Investigator: Dhayendre Moodley

Investigator: Karin Nielsen

Investigator: Lynda Stranix-Chibanda

Investigator: Taha Taha

Investigator: Gerhard Theron

Laboratory Data Manager (LDM): Andrew Bakatsias

Laboratory Data Manager (LDM): Alexander Benns

Laboratory Data Manager (LDM): Rebecca LeBlanc

Laboratory Technologist: Amy James Loftis

Laboratory Technologist: William Kabat

Pharmaceutical Company Representative: Melody Billena

Pharmacologist: Mark Mirochnick

Protocol Pharmacist: Lynette Purdue

Statistician: Konstantia Angelidou

Statistician: Paula Britto

Statistician: Sean Brummel

Statistician: Kevin Butler

Statistician: Mae Cababasay

Statistician: Terence Fenton

Statistician: David Shapiro

CTS: PROMISE Ops

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.