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

NCT02862171 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: IPM 032
• Study Type: interventional
• Target: 941
• Locations: 2 countries
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

  Safety assessments included adverse event (AE) reporting; all product-related AEs, Grade 3 or 4 AEs, SAEs.

  at least 12 months and up to 17 months

• Adherence to the Use of the 25 mg Dapivirine Vaginal Ring-004 Inserted at Monthly Intervals, in an Open-label Trial

  Determined dapivirine residual amounts in returned used vaginal rings.

  at least 12 months and up to 17 months

Secondary Outcomes (2)

• Incidence of HIV-1 Seroconversion

  at least 12 months and up to 17 months

• Number of Participants Who Acquired HIV-1 With HIV-1 Drug Resistance-associated Mutations. Infection

  at least 12 months and up to 17 months

Study Arms (1)

Dapivirine Vaginal Ring-004

EXPERIMENTAL

Dapivirine Vaginal Ring, 25 mg.Each participant will engage in the screening process for up to 45 days prior to enrolment and will use the monthly Dapivirine Vaginal Ring for a period of up to 12 months. IPM will have the option to extend this trial period.

Drug: Dapivirine Vaginal Ring-004

Interventions

Dapivirine Vaginal Ring-004 DRUG

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

Also known as: TMC-120

Dapivirine Vaginal Ring-004

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (6)

Qhakaza Mbokodo

Ladysmith, KwaZulu-Natal, 3370, South Africa

Location

MatCH Research Unit

Pietermaritzburg, KwaZulu-Natal, 3216, South Africa

Location

Madibeng Centre for Research

Brits, North West, 0250, South Africa

Location

Desmond Tutu HIV Foundation

Cape Town, Western Cape, 7675, South Africa

Location

Ndlovu Medical Centre

Elandsdoorn, South Africa

Location

MRC/UVRI Uganda Research Unit on AIDS

Entebbe, Uganda

Location

Related Publications (2)

• Steytler J, Craig C, van der Ryst E, Van Baelen B, Nuttall J, van Niekerk N, Mellors J, Parikh U, Wallis C; Ring Study and the DREAM Trial Study Teams. Characterization of Viruses in Phase 3 and Phase 3b Trials (the Ring Study and the Dapivirine Ring Extended Access and Monitoring Trial) of the Dapivirine Vaginal Ring for Human Immunodeficiency Virus Type 1 Infection Risk Reduction. Clin Infect Dis. 2023 Mar 21;76(6):996-1002. doi: 10.1093/cid/ciac875.

  PMID: 36345569 DERIVED

• Nel A, van Niekerk N, Van Baelen B, Malherbe M, Mans W, Carter A, Steytler J, van der Ryst E, Craig C, Louw C, Gwetu T, Mabude Z, Kotze P, Moraba R, Tempelman H, Gill K, Kusemererwa S, Bekker LG, Devlin B, Rosenberg Z; DREAM Study Team. Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study. Lancet HIV. 2021 Feb;8(2):e77-e86. doi: 10.1016/S2352-3018(20)30300-3.

  PMID: 33539761 DERIVED

MeSH Terms

Interventions

Dapivirine

Limitations and Caveats

Interpretation of the HIV-1 incidence rates is limited by the lack of a concurrent placebo group in IPM 032. Dapivirine residual levels in returned used rings do not provide adherence information at the time of potential exposure to and infection with HIV, eg, if a participant temporarily removes the DVR during sexual intercourse.

Results Point of Contact

• Title: Dr John Steytler
• Organization: International Partnership for Microbicides

jsteytler@ipmglobal.org

+27 21 8602300

Study Officials

• John Steytler

  International Partnership for Microbicides

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 10, 2016
• Study Start: July 12, 2016
• Primary Completion: January 11, 2019
• Study Completion: January 11, 2019
• Last Updated: October 25, 2022
• Results First Posted: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1); ZA (5)