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Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population

NCT03593655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2023-06-22

Study results available
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Summary

The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.

Conditions

  • HIV Infections

Interventions

DEVICE

Dapivirine vaginal ring

Vaginal ring containing 25 mg of dapivirine

DRUG

FTC/TDF

Tablet containing 200 mg FTC/300 mg TDF

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Gonasagrie Nair, MBChB, MPH · Emavundleni Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2021-09-09
Completion
2021-09-09
FDA Drug
Yes

Countries

  • 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 NCT03593655 on ClinicalTrials.gov