MedTrace Logo

Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)

NCT03074786 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-09-08

No results posted yet for this study

Summary

Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product every 4 weeks during the third product use period.

Conditions

Interventions

DRUG

Dapivirine

Silicone elastomer vaginal matrix ring

DRUG

Truvada

Tablets to be taken orally daily

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Dianne M Rausch, PHD · US National Institutes of Health (NIH)

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
2017-11-30
Primary Completion
2018-12-31
Completion
2020-12-30
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03074786 on ClinicalTrials.gov