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.