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

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ClinicalTrials.gov Identifier: NCT03074786
Recruitment Status : Withdrawn (Study was transferred to partner who will conduct under its own IND)
First Posted : March 9, 2017
Last Update Posted : September 8, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: Dapivirine Drug: Truvada Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Phase 2a, open-label, multi-site, two-sequence, crossover, randomized trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: 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 Name: Emtricitabine/tenofovir




Primary Outcome Measures :
  1. Safety assessed by grade 2 or higher adverse event. [ Time Frame: 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



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Ages Eligible for Study:   16 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adolescent and young adult female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074786


Locations
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South Africa
CAPRISA, eThekwini Clinical Research Site
Durban, KwaZulu-Natal, South Africa
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Gilead Sciences
Investigators
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Study Director: Dianne M Rausch, PHD US National Institutes of Health (NIH)
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Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT03074786    
Other Study ID Numbers: MTN-034/IPM 045
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Dapivirine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents