MTN 042 Study

Rationale

The MTN 042 study is a multicenter, prospective, open-label, randomized Phase 3b trial aimed at evaluating the safety, adherence, and acceptability of the Dapivirine Vaginal Ring (25 mg) and Truvada (200 mg FTC/300 mg TDF) tablet when used by African women during pregnancy. The study will test the hypothesis that both the Dapivirine Vaginal Ring (DPV VR) and Truvada are safe, well-tolerated, and will not result in adverse pregnancy outcomes compared to the general population. Through this study, researchers aim to provide valuable insights into the safety of these HIV prevention methods during pregnancy, ensuring their safe use for both mothers and infants.

Primary Objectives

1. Maternal and Infant Safety:
   To describe the maternal and infant safety profiles associated with the use of DPV VR and Truvada during pregnancy.
2. Pregnancy Outcomes:
   To characterize pregnancy outcomes associated with the use of the study products during pregnancy.

Secondary Objectives

1. Pregnancy Complications:
   To identify complications arising during pregnancy associated with the use of DPV VR and Truvada.
2. Infant Drug Levels:
   To measure infant drug levels (TFV-DP, FTC-TP, and DPV concentrations) resulting from maternal exposure to the study products.
3. Adherence:
   To assess adherence to the DPV VR and oral Truvada regimen during pregnancy.
4. Acceptability:
   To evaluate the acceptability of these products as HIV prevention methods during pregnancy.

Study Population

Healthy, HIV-uninfected pregnant women aged 18-40 years, with an uncomplicated singleton pregnancy, who are willing to be randomized to study products.

Study Sites

• Wits RHI Shandukani Research Centre (SRC)
• Other MTN-042 sites selected by the MTN Executive Committee.

Investigators

• Prof Lee Fairlie: Principal Investigator and Protocol Co-chair
• Dr Elizea Horne: Sub-Investigator
• Dr Faeezah Patel: Sub-Investigator
• Dr Mrinmayee: Sub-Investigator
• Dr Muneerah Khan: Sub-Investigator
• Dr Jeanne Coetzee: Sub-Investigator

Sponsors/Donors

• MTN – Microbicides Trials Network
• Division of AIDS (DAIDS)
• US National Institute of Mental Health (NIMH)
• National Institute of Child Health and Human Development (NICHD)

Progress Update

As of March 2024, MTN-042 has completed various screening and enrollment milestones, including the implementation of Letter of Amendment #2. Cohort 3 approval was granted in December 2022. Several in-depth interviews (IDIs) and special case IDIs have been conducted as part of the study’s qualitative research.