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

Phase 2

Withdrawn

• Conditions: HIV-1-infection
• Interventions: Drug: Truvada; Drug: Dapivirine

• Registration Number: NCT03074786
• Lead Sponsor: International Partnership for Microbicides, Inc.

Brief 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.

Detailed Description

The MTN-034/IPM 045 trial is a multi-site, randomized, two-sequence, three-period, open-label, crossover Phase 2a trial. Young adult (18-21 years old) and adolescent (16-17 years old) female participants will be enrolled in a 2:1 ratio. All the enrolled participants will use both treatment regimens in sequence. All participants will be randomly assigned to one of two treatment regimen sequences to use for the first two study product use periods, and will be able to choose between treatment regimens during the third study product use period. The total length of follow-up is approximately one and a half years which includes up to 72 weeks of product use (two 24-week periods on randomized treatment regimen and one 24-week period on freely chosen treatment regimen) plus an additional week beyond the Period 3 end visit to collect data on any new or worsening AEs.

Study Timeline

• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-08
• Study Start: 2017-11
• Primary Completion: 2018-12
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 16 through 21 years at Enrollment, verified per site standard operation procedures.
2. Able and willing to provide adequate locator information and comply with all study procedural requirements.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral Emtricitanbine/Tenofovir Disoproxil	Truvada	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to be taken orally daily
Vaginal Matrix Ring	Dapivirine	Dapivirine vaginal ring containing 25 mg of dapivirine to be replaced each month.

Primary Outcome Measures

Name	Time	Method
Safety assessed by grade 2 or higher adverse event.	12 months	To compare the safety profiles of FTC/TDF oral tablet administered daily and dapivirine vaginal matrix ring (25 mg) inserted for use of each study product in an adolescent and young adult female population

Trial Locations

Locations (1)

CAPRISA, eThekwini Clinical Research Site; 🇿🇦 Durban, KwaZulu-Natal, South Africa