Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02862171
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Tracking Information
First Submitted Date  ICMJE July 25, 2016
First Posted Date  ICMJE August 10, 2016
Last Update Posted Date February 25, 2020
Actual Study Start Date  ICMJE July 13, 2016
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Prevention
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Dapivirine Vaginal Ring-004
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2019)
850
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2016)
1400
Actual Study Completion Date  ICMJE December 10, 2018
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02862171
Other Study ID Numbers  ICMJE IPM 032
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Partnership for Microbicides, Inc.
Study Sponsor  ICMJE International Partnership for Microbicides, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account International Partnership for Microbicides, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP