NCT03234400

A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.

Detailed description

Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, and those randomized to the 100 mg and 200 mg VRs will not be told their group assignment. Participants will insert one VR to be used continuously for 13 weeks (100 mg VR or 200 mg VR) or one VR (25 mg VR) to be replaced every 4 weeks for 8 weeks, then worn for an additional 5 weeks for a total of 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Dapivirine Vaginal Ring, 25 mg	Vaginal Ring containing 25 mg dapivirine
COMBINATION_PRODUCT	Dapivirine Vaginal Ring, 100 mg	Vaginal Ring containing 100 mg dapivirine
COMBINATION_PRODUCT	Dapivirine Vaginal Ring, 200 mg	Vaginal Ring containing 200 mg dapivirine

Timeline

• Start date: 2017-12-04
• Primary completion: 2018-10-23
• Completion: 2019-01-23
• First posted: 2017-07-31
• Last updated: 2019-01-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study