Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs

PHASE3CompletedINTERVENTIONAL
Enrollment

394

Participants

Timeline

Start Date

September 24, 2020

Primary Completion Date

November 4, 2021

Study Completion Date

November 4, 2021

Conditions
HIV Infections
Interventions
DRUG

Dapivirine (DPV) Vaginal Ring (VR)-004

Vaginal ring containing 25 mg of DPV

DRUG

Truvada Tablet

Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF)

Trial Locations (4)

2001

Wits RHI Shandukani Research Centre CRS, Johannesburg

Unknown

Blantyre CRS (Johns Hopkins Research Project/College of Medicine), Blantyre

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala

Zengeza CRS, Chitungwiza

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT04140266 - Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs | Biotech Hunter | Biotech Hunter