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

International Partnership for Microbicides (IPM) logo

International Partnership for Microbicides (IPM)

Status and phase

Completed
Phase 3

Conditions

Human Immunodeficiency Virus

Treatments

Combination Product: Dapivirine Vaginal Ring

Study type

Interventional

Funder types

Industry

Identifiers

NCT02858037
MTN-025

Details and patient eligibility

About

HIV Open-label Prevention Extension (HOPE).

Full 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

Enrollment

1,456 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,456 participants in 1 patient group

HIV Open-label Prevention
Experimental group
Description:
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 MTN-020:NCT01617096 MTN-025: NCT02858037
Treatment:
Combination Product: Dapivirine Vaginal Ring

Trial documents
2

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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