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Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women

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ClinicalTrials.gov Identifier: NCT02858037
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Brief Summary:
HIV Open-label Prevention Extension (HOPE).

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Combination Product: Dapivirine Vaginal Ring Phase 3

Detailed Description:
A Phase 3B Open-Label Follow-on Trial to Assess the Continues Safety of and Adherence to a Vaginal ring Containing Dapivirine in Women

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to be replaced each month for a total period of 12 months of use.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
Study Start Date : August 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Experimental: HIV Open-label Prevention
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
Combination Product: Dapivirine Vaginal Ring
Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.



Primary Outcome Measures :
  1. Assessing the Dapivirine Ring open label use Safety Profile by Grade 2, Grade 3 and all serious AEs [ Time Frame: 13 months ]
    To characterize the safety profile associated with the open label use of the dapivirine vaginal matrix ring (25 mg) in women

  2. By measuring the residual levels of dapivirine in returned vaginal rings and Blood dapivirine levels [ Time Frame: 13 months ]
    To characterize adherence to the open label use of the dapivirine vaginal matrix ring (25 mg) in women


Secondary Outcome Measures :
  1. HIV-1 infection as measured by the protocol algorithm [ Time Frame: 13 months ]
    To assess incidence of HIV-1 infection

  2. HIV-1 drug resistance mutations among participants who acquire HIV-1, as measured by standard genotype analysis and more sensitive methods to detect low frequency drug-resistant variants [ Time Frame: 13 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 of the following criteria to be eligible for inclusion in the study

  1. Previously enrolled in MTN-020 (ASPIRE)
  2. Able and willing to provide written informed consent to be screened for and to take part in the study
  3. Able and willing to provide adequate locator information, as defined in site SOPs
  4. HIV-uninfected based on testing performed by study staff at Screening and Enrollment
  5. Using an effective method of contraception at Enrollment, and intending to use an effective method for the duration of study participation; effective methods include hormonal methods (except contraceptive ring); intrauterine contraceptive device (IUCD); and sterilization (of participant, as defined in site SOPs)
  6. At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation

Exclusion Criteria:

Women who meet any of the following criteria will be excluded from the study

  1. Study product use permanently discontinued in response to an AE or safety related concern while taking part in the MTN-020 (ASPIRE) trial
  2. Per participant report at Screening:

    1. Plans to relocate away from the study site during study participation
    2. Plans to travel away from the study site for more than three consecutive months during study participation
  3. Per participant report at Enrollment, currently taking Post-Exposure Prophylaxis (PEP)
  4. With the exception of MTN-020 (ASPIRE), participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of enrollment
  5. Is pregnant at Screening/Enrollment or planning to become pregnant in the participant's anticipated study participation period
  6. Currently breastfeeding
  7. Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STI or reproductive tract infection (RTI) requiring treatment per WHO guidelines
  8. At Screening, has a clinically apparent Grade 3 pelvic exam finding (observed by study staff) as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies
  9. Has any of the following laboratory abnormalities at Screening Visit:

    1. Aspartate aminotransferase (AST) or alanine transaminase (ALT) > Grade 3*
    2. Creatinine > Grade 3*
    3. Hemoglobin > Grade 3*
    4. Platelet count > Grade 3*
    5. Pap result ≥ Grade 3 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)
  10. Has any significant medical condition or other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives


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): NCT02858037


Locations
South Africa
Prevention for HIV and AIDS Project Recruiting
Pinetown, KwaZulu Natal, South Africa
Contact: Jared Baeten, MD, PHD    206-520-3808    jbaeten@uw.edu   
Contact: Nyaradzo Mgodi, MBCHB, MMed    +263 4 704 920    nmmgodi@uz-ucsf.co.zw   
Principal Investigator: Dr. Derek Arbuckle         
Sub-Investigator: Robert Mickel         
Sponsors and Collaborators
International Partnership for Microbicides, Inc.

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT02858037     History of Changes
Other Study ID Numbers: MTN-025
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases