Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Dapivirine Vaginal Ring
Intervention description: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
Intervention MeSH terms: Dapivirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
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)
Enrollment: 1456.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      HIV Open-label Prevention Extension (HOPE).
    

Eligibility 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

          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

             -