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

NCT03074786 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: MTN-034/IPM 045
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vaginal Matrix Ring

EXPERIMENTAL

Dapivirine vaginal ring containing 25 mg of dapivirine to be replaced each month.

Drug: Dapivirine

Oral Emtricitanbine/Tenofovir Disoproxil

EXPERIMENTAL

Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to be taken orally daily

Drug: Truvada

Interventions

Dapivirine DRUG

Silicone elastomer vaginal matrix ring

Also known as: Vaginal Ring

Vaginal Matrix Ring

Truvada DRUG

Tablets to be taken orally daily

Also known as: Emtricitabine/tenofovir

Oral Emtricitanbine/Tenofovir Disoproxil

Eligibility Criteria

• Age: 16 Years - 21 Years
• Gender Eligibility Details: Adolescent and young adult female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Become Pregnant and/or use oral PrEP outside the context of study.
• At Screening or Enrollment, has a positive HIV test.
• Age 16 through 21 years at Enrollment, verified per site standard operation procedures.
• Able and willing to provide adequate locator information and comply with all study procedural requirements.

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead
• Gilead Sciences: collaborator

Study Sites (1)

CAPRISA, eThekwini Clinical Research Site

Durban, KwaZulu-Natal, South Africa

Location

Related Publications (1)

• Ngure K, Browne EN, Reddy K, Friedland BA, van der Straten A, Palanee-Phillips T, Nakalega R, Gati B, Kalule HN, Siziba B, Soto-Torres L, Nair G, Garcia M, Celum C, Roberts ST. Correlates of Adherence to Oral and Vaginal Pre-exposure Prophylaxis (PrEP) Among Adolescent Girls and Young Women (AGYW) Participating in the MTN-034/REACH Trial. AIDS Behav. 2024 Sep;28(9):2990-3000. doi: 10.1007/s10461-024-04382-3. Epub 2024 Jun 9.

  PMID: 38852114 DERIVED

MeSH Terms

Interventions

Dapivirine; Contraceptive Devices, Female; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Contraceptive Devices; Equipment and Supplies; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Dianne M Rausch, PHD

  US National Institutes of Health (NIH)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2a, open-label, multi-site, two-sequence, crossover, randomized trial

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: March 9, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 30, 2020
• Last Updated: September 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)