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

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ClinicalTrials.gov Identifier: NCT02862171
Recruitment Status : Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

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

Condition or disease Intervention/treatment Phase
HIV Prevention Drug: Dapivirine Vaginal Ring-004 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
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
Actual Study Start Date : July 13, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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 :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT02862171     History of Changes
Other Study ID Numbers: IPM 032
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018