Phase 3
N=941
To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women
HIV Prevention
Bottom Line
View on ClinicalTrials.gov: NCT02862171 ↗Enrolled (actual)
941
Serious AEs
2.1%
Results posted
Oct 2022
Primary outcome: Primary: The Safety Profile of the 25 mg Dapivirine Vaginal Ring-004, When Inserted at Monthly Intervals. Participants Attended RC at Monthly Visits (up to Max of Three Monthly Visits) Followed by 3-monthly Follow-up Visits. — 616; 20; 3; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dapivirine Vaginal Ring-004 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- International Partnership for Microbicides, Inc.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Safety Profile of the 25 mg Dapivirine Vaginal Ring-004, When Inserted at Monthly Intervals. Participants Attended RC at Monthly Visits (up to Max of Three Monthly Visits) Followed by 3-monthly Follow-up Visits. |
616; 20; 3; 37; 6; 1 | — |
| PRIMARY Adherence to the Use of the 25 mg Dapivirine Vaginal Ring-004 Inserted at Monthly Intervals, in an Open-label Trial |
20.77; 20.57; 20.59; 20.83; 20.61; 20.70 | — |
| SECONDARY Incidence of HIV-1 Seroconversion |
1.8 | — |
| SECONDARY Number of Participants Who Acquired HIV-1 With HIV-1 Drug Resistance-associated Mutations. Infection |
5 | — |
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
Eligibility Criteria
Inclusion Criteria
Women must meet all the following criteria to be eligible to enrol in the trial:
- Previously enrolled in the IPM 027 trial
- Available for all visits and consent to follow all procedures scheduled for the trial
- Using an effective method of contraception at the Enrolment Visit, and intending to use an effective contraceptive method for the duration of trial participation, unless post-menopausal with no history of menses for one year prior to screening
- HIV-negative as determined by the HIV algorithm applied at Screening/Pre- Enrolment
- Willing to refrain from participation in another research trial using drugs, vaccines, medical devices and microbicides for the duration of the IPM 032 trial
- Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures (e.g., by home visit or telephone; or via family or close neighbour contacts); confidentiality to be maintained.
Exclusion Criteria
Women who meet any of the following criteria are NOT eligible to enrol in the trial:
- Investigational product use permanently discontinued in response to an AE (where the AE was considered related to investigational product) or safety-related concern while taking part in the IPM 027 trial
- Participant self-report of taking post-exposure prophylaxis (PEP) within ≤ 2 months at Screening Visit Note: Participants may be enrolled after completing the PEP regimen and a negative HIV test was documented at least 2 months prior to screening for IPM 032
- Currently pregnant, intends to become pregnant or currently breast-feeding
- Known drug abuse or alcohol dependence in the 12 months prior to screening
- Participated in another research trial (other than IPM 027) using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 30 days prior to screening
- Any new illness or condition(s), chronic condition(s) or abnormal laboratory finding(s) that, in the opinion of the investigator, might put the participant at risk, or interfere with the trial objectives or the participant's adherence to trial requirements
Data sourced from ClinicalTrials.gov (NCT02862171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.