To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women

NCT02862171 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 941

Last updated 2022-10-25

Study results available
· View outcomes & findings →

Summary

A follow-on, open label trial to assess continued safety of and adherence to the Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women

Conditions

  • HIV Prevention

Interventions

DRUG

Dapivirine Vaginal Ring-004

To assess the safety profile of the 25 mg Dapivirine Vaginal Ring-004, when inserted at monthly intervals, in an open-label trial

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • John Steytler · International Partnership for Microbicides

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-12
Primary Completion
2019-01-11
Completion
2019-01-11
FDA Drug
Yes

Countries

  • South Africa
  • Uganda

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02862171 on ClinicalTrials.gov