MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used during pregnancy. Approximately 550 healthy, HIV-uninfected women who are 18-45 years of age, pregnant with a single child, and willing to use study product during pregnancy will be enrolled in MTN-042 along with their newborn infants. Participants will be enrolled into one of three 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: 12 0/7 weeks – 29 6/7 weeks 250 women
The primary objectives are to describe the maternal and infant safety profile and the pregnancy outcomes associated with study product exposure during pregnancy. The study will also assess pregnancy complications and infant levels of study drugs associate with product exposure as well as adherence to and acceptability of open label use of the dapivirine VR and oral Truvada in pregnant women.
The three cohorts will be enrolled 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 36 weeks, depending on GA at enrollment and timing of pregnancy outcome. Enrolled newborn participants will be followed up for approximately 1 year.
The first clinical research site was activated on 9 January 2020. Accrual of Cohort 1 was just completed on April 13, 2021. Enrollment to Cohort 2 will continue after the interim safety review of Cohort 1.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health