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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-18

Study Completion Date

2018-10-10

Brief Summary

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HIV Open-label Prevention Extension (HOPE).

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Detailed Description

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

Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

MTN-020:NCT01617096 MTN-025: NCT02858037

Group Type EXPERIMENTAL

Dapivirine Vaginal Ring

Intervention Type COMBINATION_PRODUCT

Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.

Interventions

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Dapivirine Vaginal Ring

Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Steytler

Role: STUDY_DIRECTOR

International Partnership for Microbicides

Locations

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Johns Hopkins University Research Project

Blantyre, , Malawi

Site Status

Malawi Clinical Research Center

Lilongwe, , Malawi

Site Status

Medical Research Council of South Africa

Westville, Durban, South Africa

Site Status