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MTN-042 is an open label, multi-site, randomized (2:1 to VR:tablet) trial designed to assess the safety and pharmacokinetics (PK) of the dapivirine VR and FTC/TDF oral tablet when used during pregnancy. Approximately 750 healthy, HIV-uninfected women who are 18-45 years of age, with an uncomplicated singleton pregnancy, and willing to be randomized and use study product during pregnancy will be enrolled in MTN-042 along with their newborn infants. Participants will be enrolled into one of four cohorts, with onset of dosing period for each cohort to occur within the following gestational age (GA) ranges:

  • Cohort 1: 36 0/7 weeks – 37 6/7 weeks 150 women
  • Cohort 2: 30 0/7 weeks – 35 6/7 weeks 150 women
  • Cohort 3: 20 0/7 weeks – 29 6/7 weeks 150 women
  • Cohort 4: 12 0/7 weeks – 19 6/7 weeks 300 women

The cohorts will be filled sequentially, with pauses between cohorts to review interim safety data. Enrolled maternal participants will be on study product for up to 30 weeks and followed up for up to 34 weeks, depending on GA at enrollment and timing of pregnancy outcome. Enrolled newborn participants will be followed up for approximately 4 weeks. For both mothers and infants, enrollment in MTN-016 (EMBRACE) will be encouraged and facilitated by study sites.

See

Meeting Report: Stakeholders Consultation on MTN-042

Protocol Chair(s)
Bunge, Katherine (Protocol Chair)
Fairlie, Lee (Protocol Co-Chair)
Makanani, Bonus (Protocol Chair)
Protocol Title
Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring (VR) and Oral TRUVADA Use in Pregnancy
Status
In Development
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
Pregnant  
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