Clinical Trials

MainTitle

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

This study has been completed
Sponsor
International Partnership for Microbicides, Inc.


Information provided by (Responsible Party)
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier
NCT02862171

First received: July 25, 2016
Last updated: January 16, 2019
Last Verified: January 2019
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Prevention

Drug : Dapivirine Vaginal Ring-004
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Follow-On, Open-Label Trial To Assess Continued Safety Of And Adherence To The Dapivirine (25 Mg) Vaginal Ring-004 In Healthy, HIV-Negative Women

Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures

  • Gynaecological assessments including pelvic/speculum examination. [ Time Frame: 12 months ]
    To assess the safety profile of the 25 mg Dapivirine Vaginal Ring-004, when inserted at monthly intervals, in an open-label trial
  • Determined dapivirine residual amounts in returned used vaginal rings and/or Measured concentrations of dapivirine in plasma and/or vaginal fluids [ Time Frame: 12 months ]
    To assess adherence to the use of the 25 mg Dapivirine Vaginal Ring-004 inserted at monthly intervals, in an open-label trial
Secondary Outcome Measures:
  • Rapid and specialised laboratory testing according to a pre-specified HIV testing algorithm [ Time Frame: 12 months ]
    To assess the incidence of HIV-1 seroconversion
  • Viral genotype resistance testing methods [ Time Frame: 12 months ]
    To assess the frequency of HIV-1 drug resistance in women who acquire HIV-1 infection

Enrollment: 850
Study Start Date: July 13, 2016
Study Completion Date: December 10, 2018
Primary Completion Date: December 10, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Dapivirine Vaginal Ring-004
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

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 40 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:
Women must meet all the following criteria to be eligible to enrol in the trial:

    1. Previously enrolled in the IPM 027 trial
    2. Available for all visits and consent to follow all procedures scheduled for the trial
    3. 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
    4. HIV-negative as determined by the HIV algorithm applied at Screening/Pre- Enrolment
    5. Willing to refrain from participation in another research trial using drugs, vaccines, medical devices and microbicides for the duration of the IPM 032 trial
    6. 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:
    1. 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
    2. 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
    3. Currently pregnant, intends to become pregnant or currently breast-feeding
    4. Known drug abuse or alcohol dependence in the 12 months prior to screening
    5. 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
    6. 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

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02862171

    Locations

    South Africa
    Madibeng Centre for Research
    Brits, South Africa
    Desmond Tutu HIV Foundation
    Cape Town, South Africa
    Ndlovu Medical Centre
    Elandsdoorn, South Africa
    Qhakaza Mbokodo
    Ladysmith, South Africa
    MatCH Edendale Research Center
    Pietermaritzburg, South Africa
    Uganda
    MRC/UVRI Uganda Research Unit on AIDS
    Entebbe, Uganda

    Sponsors and Collaborators

    International Partnership for Microbicides, Inc.
    More Information

    More Information


    Responsible Party: International Partnership for Microbicides, Inc.  
    ClinicalTrials.gov Identifier: NCT02862171   History of Changes  
    Other Study ID Numbers: IPM 032  
    Study First Received: July 25, 2016  
    Last Updated: January 16, 2019  

    Additional relevant MeSH terms:
    Dapivirine

    ClinicalTrials.gov processed this data on September 18, 2019
    This information is provided by ClinicalTrials.gov.