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

Last updated: October 24, 2022
Sponsor: International Partnership for Microbicides, Inc.
Overall Status: Completed

Phase

3

Condition

Hiv

Hiv Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT02858037
MTN-025
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

HIV Open-label Prevention Extension (HOPE).

Eligibility Criteria

Inclusion

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 takepart 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 aneffective method for the duration of study participation; effective methods includehormonal 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 studiesinvolving drugs, medical devices, vaginal products, or vaccines for the duration ofstudy participation

Exclusion

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 relatedconcern 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 monthsduring 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 studyinvolving drugs, medical devices, vaginal products, or vaccines, within 60 days ofenrollment 5. Is pregnant at Screening/Enrollment or planning to become pregnant in theparticipant's anticipated study participation period 6. Currently breastfeeding 7. Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STIor reproductive tract infection (RTI) requiring treatment per WHO guidelines 8. At Screening, has a clinically apparent Grade 3 pelvic exam finding (observed by studystaff) as per the Division of AIDS Table for Grading the Severity of Adult andPediatric 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 inMicrobicide Studies Addendum 1 to the DAIDS Table for Grading Adult and PediatricAdverse Events, Version 1.0, December 2004 (Clarification dated August 2009) 10. Has any significant medical condition or other condition that, in the opinion of theIoR/designee, would preclude informed consent, make study participation unsafe,complicate interpretation of study outcome data, or otherwise interfere with achievingthe study objectives

Study Design

Total Participants: 1456
Study Start date:
July 18, 2016
Estimated Completion Date:
October 10, 2018

Study 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

Connect with a study center

  • Johns Hopkins University Research Project

    Blantyre,
    Malawi

    Site Not Available

  • Malawi Clinical Research Center

    Lilongwe,
    Malawi

    Site Not Available

  • Medical Research Council of South Africa

    Westville, Durban 3630
    South Africa

    Site Not Available

  • WRHI Clinical Research Center

    Johannesburg, Gauteng
    South Africa

    Site Not Available

  • Botha's Hill Clinical Research Center

    Durban, Kwa-Zulu Natal
    South Africa

    Site Not Available

  • Chatsworth Clinical Research Center

    Durban, Kwa-Zulu Natal
    South Africa

    Site Not Available

  • Prevention for HIV and AIDS Project

    Pinetown, KwaZulu Natal
    South Africa

    Site Not Available

  • Isipingo Clinical Research Center

    Durban, KwaZulu-Natal
    South Africa

    Site Not Available

  • Tongaat Clinical Research Center

    Durban, KwaZulu-Natal
    South Africa

    Site Not Available

  • Verulam Clinical Research Center

    Durban, KwaZulu-Natal 4340
    South Africa

    Site Not Available

  • Emavundleni Research Centre

    Cape Town, Western Cape 7750
    South Africa

    Site Not Available

  • eThekwini Clinical Research Center

    Durban, 4001
    South Africa

    Site Not Available

  • Wits Reproductive Health and HIV Institute Research Centre

    Johannesburg,
    South Africa

    Site Not Available

  • MU-JHU Research Collaboration

    Kampala,
    Uganda

    Site Not Available

  • Makerere University - Johns Hopkins University Research Collaboration Clinical Research Center

    Kampala,
    Uganda

    Site Not Available

  • Seke South Clinical Research Center

    Harare,
    Zimbabwe

    Site Not Available

  • Spilhaus Clinical Research Center

    Harare,
    Zimbabwe

    Site Not Available

  • Zengeza Clinical Research Center

    Harare,
    Zimbabwe

    Site Not Available

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