MTN 043/ B-PROTECTED

Status:Completed
Phase:Open Label, III
Principal Investigator(s):Maxensia Owor, MBChB, MMed (Paed), MPH; Lisa Noguchi, PhD, CNM; Jennifer Balkus, PhD, MPH
Objective:MTN 043 is a Phase 3B, randomized, open label trial with 12 weeks exposure to DVR on oral 200mg emtricitabine (FTC)/ 300mg tenofovir disoproxil fumarate (TDF) tablet. The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.August 2022 update: Follow-up phase was completed in November 2021, and preliminary results were presented AIDS 2022- 197 mother-infant pairs enrolled (148 on DVR, 49 on oral PrEP) - Median age of mothers was 29 years and infants was 9 weeks - No product related SAEs in mothers; No infant AEs related to product for either arm "Favorable safety profile and previous data demonstrating low drug transfer to breastmilk support updates of WHO and national guidelines to include breastfeeding people when recommending the DVR as an HIV prevention choice"Last update August 8, 2022
Prevention Option(s):Microbicides
Study Design:Double-blind, Open label, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 Mothers will use one DPV VR continuously for approximately one month, replacing the DPV VR each month for approximately three months.
Mode of DeliveryRing
ARMsExperimental
DescriptionExperimental: Group B: Truvada Tablet Mothers will take one Truvada oral tablet daily for approximately three months.
Mode of DeliveryTablet
ARMsActive Comparator
Official Code: NCT04140266
Trial Sponsors: NIAID (DAIDS-ES: 38591)
Start Date
End Date
August 24, 2020
November 4, 2021
Enrollment:394
Age range: 2 Months ↔ any
Population:Adolescents and Young People, Cisgender Women, Pregnant and Lactating Populations