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 weeksJuly 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:Open label, Randomized
Arms and Assigned Interventions
DescriptionExperimental: 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 DeliveryGel, Tablet
ARMs
DescriptionExperimental: 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 DeliveryTablet
ARMsActive Comparator
DescriptionExperimental: 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 DeliveryRing
ARMsExperimental
DescriptionExperimental: 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 DeliveryTablet
ARMsActive Comparator
DescriptionExperimental: 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 DeliveryRing
ARMsExperimental
DescriptionExperimental: 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 DeliveryTablet
ARMsActive Comparator
DescriptionExperimental: 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 DeliveryRing
ARMsExperimental
DescriptionExperimental: 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 DeliveryTablet
ARMsActive Comparator
Official Code:
NCT03965923
Trial Sponsors:
NIAID (DAIDS-ES: 38544)
Start Date
End Date
January 9, 2020
April 20, 2023
Enrollment:750
Age range:
18 Years ↔
40 Years
Population:Cisgender Women, Pregnant and Lactating Populations