Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Combination Product: Dapivirine Vaginal Ring
- Registration Number
- NCT02858037
- Lead Sponsor
- International Partnership for Microbicides, Inc.
- Brief Summary
HIV Open-label Prevention Extension (HOPE).
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1456
Women must meet all of the following criteria to be eligible for inclusion in the study
- Previously enrolled in MTN-020 (ASPIRE)
- Able and willing to provide written informed consent to be screened for and to take part in the study
- Able and willing to provide adequate locator information, as defined in site SOPs
- HIV-uninfected based on testing performed by study staff at Screening and Enrollment
- 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)
- 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
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:
- Plans to relocate away from the study site during study participation
- 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:
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) > Grade 3*
- Creatinine > Grade 3*
- Hemoglobin > Grade 3*
- Platelet count > Grade 3*
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HIV Open-label Prevention Dapivirine Vaginal Ring 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
- Primary Outcome Measures
Name Time Method The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women 13 months Number of participants Grade 2, Grade 3, and all serious Adverse Events.
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women 13 months By measuring the residual levels of dapivirine in returned used vaginal rings.
- Secondary Outcome Measures
Name Time Method Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations. 13 months 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
Incidence of HIV-1 Infection 13 months HIV-1 infection as measured by the protocol algorithm
Trial Locations
- Locations (17)
Emavundleni Research Centre
🇿🇦Cape Town, Western Cape, South Africa
Malawi Clinical Research Center
🇲🇼Lilongwe, Malawi
Makerere University - Johns Hopkins University Research Collaboration Clinical Research Center
🇺🇬Kampala, Uganda
MU-JHU Research Collaboration
🇺🇬Kampala, Uganda
Johns Hopkins University Research Project
🇲🇼Blantyre, Malawi
Tongaat Clinical Research Center
🇿🇦Durban, KwaZulu-Natal, South Africa
Verulam Clinical Research Center
🇿🇦Durban, KwaZulu-Natal, South Africa
WRHI Clinical Research Center
🇿🇦Johannesburg, Gauteng, South Africa
Medical Research Council of South Africa
🇿🇦Westville, Durban, South Africa
Botha's Hill Clinical Research Center
🇿🇦Durban, Kwa-Zulu Natal, South Africa
Chatsworth Clinical Research Center
🇿🇦Durban, Kwa-Zulu Natal, South Africa
Wits Reproductive Health and HIV Institute Research Centre
🇿🇦Johannesburg, South Africa
eThekwini Clinical Research Center
🇿🇦Durban, South Africa
Seke South Clinical Research Center
🇿🇼Harare, Zimbabwe
Spilhaus Clinical Research Center
🇿🇼Harare, Zimbabwe
Zengeza Clinical Research Center
🇿🇼Harare, Zimbabwe
Isipingo Clinical Research Center
🇿🇦Durban, KwaZulu-Natal, South Africa