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

HIV-1-infection Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03074786
• Other study ID #: MTN-034/IPM 045
• Status: Withdrawn
• Phase: Phase 2
• First received: February 10, 2017
• Last updated: September 5, 2017
• Start date: November 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2017
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• Dapivirine
Silicone elastomer vaginal matrix ring
• Truvada
Tablets to be taken orally daily

Locations

Country	Name	City	State
South Africa	CAPRISA, eThekwini Clinical Research Site	Durban	KwaZulu-Natal

Sponsors (2)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.	Gilead Sciences

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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