NCT02858037

Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women

A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,456 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

HIV Open-label Prevention Extension (HOPE).

Detailed description

A Phase 3B Open-Label Follow-on Trial to Assess the Continues Safety of and Adherence to a Vaginal ring Containing Dapivirine in Women

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Dapivirine Vaginal Ring	Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.

Timeline

• Start date: 2016-07-18
• Primary completion: 2018-10-10
• Completion: 2018-10-10
• First posted: 2016-08-08
• Last updated: 2022-10-25
• Results posted: 2022-10-25

Locations

17 sites across 4 countries: Malawi, South Africa, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study