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MTN 042/ DELIVER

Status
Ongoing
Phase
III
Principal Investigator(s)
Katherine Bunge, MD, MPH; Bonus Makanani, MBBS, FCOG(SA)
Objective

The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.

Cohort 1: 36 0/7 weeks - 37 6/7 weeks
Cohort 2: 30 0/7 weeks - 35 6/7 weeks
Cohort 3: 20 0/7 weeks - 29 6/7 weeks
Cohort 4: 12 0/7 weeks - 19 6/7 weeks


July 2022 update: Interim Review Panel (IRP) conducted its review of safety data from Cohort 2, and finding no concerns, recommended the study proceed.



Last updated July 6, 2021

Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Experimental: Cohort 1: Dapivirine (DPV) Vaginal Ring (VR) Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Mode of Delivery
Gel
Tablet
Products
Dapivirine Ring
TDF/FTC (Truvada)
Description
Experimental: Cohort 1: Truvada Tablet Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Active Comparator
Description
Experimental: Cohort 2: Dapivirine (DPV) Vaginal Ring (VR) Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
Experimental: Cohort 2: Truvada Tablet Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Active Comparator
Description
Experimental: Cohort 3: Dapivirine (DPV) Vaginal Ring (VR) Participants in Cohort 3 (20 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
Experimental: Cohort 3: Truvada Tablet Participants in Cohort 3 (20 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Active Comparator
Description
Experimental: Cohort 4: Dapivirine (DPV) Vaginal Ring (VR) Participants in Cohort 4 (12 0/7 weeks - 19 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
Experimental: Cohort 4: Truvada Tablet Participants in Cohort 4 (12 0/7 weeks - 19 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Active Comparator
Official Code
NCT03965923
Trial Sponsors
NIAID (DAIDS-ES: 38544)
January 2020
April 2023
Enrollment
750
18
Years
40
Years
Population
Pregnant women
Women
Sites

Blantyre CRS

Malawi

WRHI CRS

South Africa

MU-JHU Research Collaboration CRS

Kampala
Uganda

Zengeza CRS

Harare
Zimbabwe