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

A Phase 2a Crossover Trial 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

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.

Study Overview

• Status: Withdrawn
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Dapivirine; Drug: Truvada

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa
      • CAPRISA, eThekwini Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Exclusion Criteria:

1. Become Pregnant and/or use oral PrEP outside the context of study.
2. At Screening or Enrollment, has a positive HIV test.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal Matrix Ring; Dapivirine vaginal ring containing 25 mg of dapivirine to be replaced each month.	Drug: Dapivirine; Silicone elastomer vaginal matrix ring; Other Names: Vaginal Ring
Experimental: Oral Emtricitanbine/Tenofovir Disoproxil; Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to be taken orally daily	Drug: Truvada; Tablets to be taken orally daily; Other Names: Emtricitabine/tenofovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by grade 2 or higher adverse event.	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	12 months

Collaborators and Investigators

• Sponsor: International Partnership for Microbicides, Inc.
• Collaborators: Gilead Sciences
• Investigators: Study Director: Dianne M Rausch, PHD, US National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine; Dapivirine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: MTN-034/IPM 045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No