Clinical Trials

MainTitle

Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in 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
NCT02858037

First received: July 18, 2016
Last updated: October 11, 2018
Last Verified: October 2018
History of Changes
Purpose

Purpose

HIV Open-label Prevention Extension (HOPE).

Condition Intervention Phase
Human Immunodeficiency Virus

Combination Product : Dapivirine Vaginal Ring
Phase 3

Study Type: Interventional
Study Design: 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

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

Primary Outcome Measures

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

Enrollment: 1576
Study Start Date: August 2016
Study Completion Date: October 10, 2018
Primary Completion Date: October 10, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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

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 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
  • Study product use permanently discontinued in response to an AE or safety related concern while taking part in the MTN-020 (ASPIRE) trial
  • 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
  • Per participant report at Enrollment, currently taking Post-Exposure Prophylaxis (PEP)
  • 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
  • Is pregnant at Screening/Enrollment or planning to become pregnant in the participant's anticipated study participation period
  • Currently breastfeeding
  • Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STI or reproductive tract infection (RTI) requiring treatment per WHO guidelines
  • 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
  • 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)
  • 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

    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: NCT02858037

    Locations

    South Africa
    Prevention for HIV and AIDS Project
    Pinetown, KwaZulu Natal, South Africa

    Sponsors and Collaborators

    International Partnership for Microbicides, Inc.
    More Information

    More Information


    Responsible Party: International Partnership for Microbicides, Inc.  
    ClinicalTrials.gov Identifier: NCT02858037   History of Changes  
    Other Study ID Numbers: MTN-025  
    Study First Received: July 18, 2016  
    Last Updated: October 11, 2018  
    Individual Participant Data    
    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
    Dapivirine

    ClinicalTrials.gov processed this data on May 24, 2019
    This information is provided by ClinicalTrials.gov.