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Clinical trialNCT01061151CompletedPhase 3Interventional

Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment3,747HIV Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Mary Glenn Fowler, MD, MPH

    Johns Hopkins Medical Institute, Makerere U.-JHU Research Collaboration

    Study Chair

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

India
  • Byramjee Jeejeebhoy Medical College (bjmc) Crs

    Pune, Maharashtra, India

Malawi
  • Blantyre Crs

    Blantyre, Malawi

  • Malawi Crs

    Lilongwe, Malawi

South Africa
  • Shandukani Research Crs

    Johannesburg, Gauteng, South Africa

  • Soweto Impaact Crs

    Johannesburg, Gauteng, South Africa

  • Durban Paediatric Hiv Crs

    Durban, KwaZulu-Natal, South Africa

  • Umlazi Crs

    Durban, KwaZulu-Natal, South Africa

  • Family Clinical Research Unit (fam-Cru) Crs

    Cape Town, Western Cape, South Africa

Tanzania
  • Kilimanjaro Christian Medical Centre (kcmc)

    Moshi, Tanzania

Uganda
  • Mu-Jhu Research Collaboration (mujhu Care Ltd) Crs

    Kampala, Uganda

Zambia
  • George Crs

    Lusaka, Zambia

Zimbabwe
  • Seke North Crs

    Chitungwiza, Zimbabwe

  • St Mary'S Crs

    Chitungwiza, Zimbabwe

  • Harare Family Care Crs

    Harare, Zimbabwe

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Emtricitabine-tenofovir disoproxil fumarateEmtricitabine-tenofovir disoproxil fumarate tailLamivudine / zidovudineLopinavir / ritonavirNevirapine: Antepartum MothersNevirapine: Infant extendedNevirapine: Infant short-courseZidovudine →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Mar 2011
Primary completion
30 Sept 2016
Completion
30 Sept 2016
Last update posted
11 Feb 2022
Registered enrollment
3,747
Registry id
NCT01061151

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.