MTN-043

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MTN-043 is a Phase 3B, open-label, randomized (3:1), multi-site, mother-infant pair PK study designed to assess the safety, PK, adherence, and acceptability of the 25 mg dapivirine VR inserted every 4-weeks and the once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries during breastfeeding. Approximately 200 healthy, HIV-uninfected breastfeeding women and their healthy infants between 6-12 weeks old (inclusive) will be enrolled in MTN-043. The primary objectives are to describe the maternal and infant safety profile associated with study product exposure during breastfeeding in both study arms. The study will also investigate the adherence to and acceptability of open-label use of both products in breastfeeding women.  Enrolled maternal participants will be on study product for approximately 12 weeks, and enrolled mother-infant pairs will be followed up for up to three and a half months.

The first clinical research site of the study was activated on August 24, 2020. The study is currently enrolling participants.

Protocol Chair(s)
Noguchi, Lisa (Protocol Co-Chair)
Protocol Title
Phase 3B, Open-label, Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
Status
Enrolling
Formulation
Oral Tablet
Vaginal Ring
Drug
Dapivirine
Truvada® (emtricitabine +tenofovir disoproxil fumarate)
Study Focus/Product Administration
Oral
Vaginal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase IIIB
Countries
Malawi
South Africa
Uganda
Zimbabwe
Population
Infants
Lactating  
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Sponsor(s)
DAIDS

Source URL: https://www.mtnstopshiv.org/research/studies/mtn-043