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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03519503
Date of registration:	02/11/2017
Prospective Registration:	No
Primary sponsor:	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Public title:	Infant Peri-Exposure Prophylaxis to Prevent HIV-1 Transmission by Breastfeeding: Mechanisms & Safety
Scientific title:	Promoting Infant Health and Nutrition in Sub-Saharan Africa (PROMISE): Safety and Efficacy of Infant Peri-Exposure Prophylaxis (PEP) to Prevent HIV-1 Transmission by Breastfeeding Mechanisms & Safety (M&S)
Date of first enrolment:	February 27, 2017
Target sample size:	562
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03519503
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Burkina Faso	South Africa	Uganda	Zambia

Contacts

Name:	Chipepo KANKASA, MD, PhD
Address:
Telephone:
Email:
Affiliation:	University of Zambia

Name:	James K TUMWINE, MD,PhD
Address:
Telephone:
Email:
Affiliation:	University of Makerere, Uganda

Name:	Mandisa SINGATA, PhD
Address:
Telephone:
Email:
Affiliation:	University of Fort Hare, South Africa

Name:	Nicolas MEDA, MD, PhD
Address:
Telephone:
Email:
Affiliation:	University of Ouagadougou, Burkina Faso

Key inclusion & exclusion criteria

Inclusion Criteria:

- Having taken part in the ANRS 12174 PROMISE-PEP trial until the final (50 week) visit;

- Not being infected with HIV during the duration of the ANRS 12174 PROMISE-PEP trial.

Exclusion Criteria:

- Parent refusal to participate in the study after information about the PROMISE M&S
project is given.

Age minimum: 5 Years
Age maximum: 8 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth and Development

Intervention(s)

Primary Outcome(s)

HIV seroconversion [Time Frame: From date of last visit in PROMISE PEP study (week 50 of follow-up) until the date of PROMISE-PEP M&S inclusion visit, assessed up to 96 months]

Secondary Outcome(s)

Weight [Time Frame: Cross-sectional survey during the inclusion visit]

Height [Time Frame: Cross-sectional survey during the inclusion visit]

Long term survival [Time Frame: From date of last visit in PROMISE PEP study (week 50 of follow-up) until the date of first documented date of death from any cause, assessed up to 96 months]

Biological disorders [Time Frame: Cross-sectional survey during the inclusion visit]

Infant growth [Time Frame: Cross-sectional survey during the inclusion visit]

Mortality rate [Time Frame: From date of last visit in PROMISE PEP study (week 50 of follow-up) until the date of first documented date of death from any cause, assessed up to 96 months]

Neuro-psychological development [Time Frame: Cross-sectional survey during the inclusion visit]

Secondary ID(s)

ANRS 12341 PROMISE-PEP M&S

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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