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

NCT04140266 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2023-08-04

Study results available
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Summary

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.

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)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Maxensia Owor, MBChB, MMed, MPH · MU-JHU CARE

  • Lisa Noguchi, PhD, CNM · Johns Hopkins Bloomberg School of Public Health

  • Jen Balkus, PhD, MPH · Hans Rosling Center for Population Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2021-11-04
Completion
2021-11-04
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 NCT04140266 on ClinicalTrials.gov