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

International Partnership for Microbicides (IPM)

Status and phase: Withdrawn; Phase 2

Conditions: HIV-1-infection

Treatments: Drug: Truvada; Drug: Dapivirine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03074786

MTN-034/IPM 045

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 16 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Vaginal Matrix Ring

Experimental group

Description:

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

Treatment:

Drug: Dapivirine

Oral Emtricitanbine/Tenofovir Disoproxil

Experimental group

Description:

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

Treatment:

Drug: Truvada