HIV-1-infection
Conditions
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.
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.
Interventions
DRUGDapivirine
Silicone elastomer vaginal matrix ring
DRUGTruvada
Tablets to be taken orally daily
Sponsors
Gilead Sciences
International Partnership for Microbicides, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Phase 2a, open-label, multi-site, two-sequence, crossover, randomized trial
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 21 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by grade 2 or higher adverse event. | 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 |
Countries
South Africa
Outcome results
None listed