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Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

NCT03965923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1104

Last updated 2025-08-12

Study results available
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Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

Dapivirine (DPV) Vaginal Ring (VR)

Vaginal ring containing 25 mg of DPV

DRUG

Truvada Tablet

Tablet taken orally

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Katherine Bunge, MD, MPH · University of Pittsburgh

  • Felix Mhlanga, MBChB, MMed · Zengeza Clinical Research Site

  • Lee Fairlie · Wits RHI Shandukani Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2024-05-13
Completion
2024-05-13
FDA Drug
Yes

Countries

  • Malawi
  • South Africa
  • Uganda
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03965923 on ClinicalTrials.gov