Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women

Inclusion Criteria

• Age 45 through 65 years (inclusive) at Screening, verified per site SOPs
• Per participant report, postmenopausal at Screening, defined as amenorrhoeic for the past 12 months (minimum) or at least 6 months status post-bilateral oophorectomy
• Follicle-stimulating hormone (FSH) level at 40 mIU/ml or higher at Screening
• Able and willing to provide written informed consent to be screened for and enrolled in MTN-024/IPM 031
• Able to communicate in spoken and written English
• Able and willing to comply with all study procedural requirements
• Willing to only use study provided and/or approved vaginal products throughout the duration of study participation.
• Willing to abstain from inserting study approved lubricant into the vagina for 72 hours prior to each visit
• Willing to abstain from vaginal intercourse for 72 hours prior to each visit
• In general good health as determined by the Investigator of Record (IoR)/designee at Screening and Enrollment
• Able and willing to provide adequate locator information, as defined in site SOPs
• HIV-uninfected based on testing performed at Screening (per protocol algorithm in Appendix II)
• Per participant report at Screening and Enrollment, agrees to use male latex condoms for sexual intercourse
• Per participant report at Screening and Enrollment, states a willingness to refrain from inserting any non-study vaginal products or objects into the vagina including, but not limited to spermicides, female condoms, diaphragms, topical or systemic hormone replacement therapy, including vaginal estrogens, and/or hormonal contraceptives, vaginal medications, menstrual cups, cervical caps (or any other vaginal barrier method), vaginal douches, lubricants and moisturizers, sex toys (vibrators, dildos, etc.), for the duration of the study participation.

Note: Use of study approved lubricant is permitted.

• 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

Participants in the biopsy subset must also meet the following criteria at Screening to be eligible for inclusion:

• Willing to abstain from inserting anything into the vagina for 72 hours following the collection of biopsies, including abstaining from vaginal intercourse
• Anatomy sufficient for the collection of cervical biopsies

Exclusion Criteria

• 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 4 consecutive weeks during study participation
• Pregnant at screening Note: A documented negative pregnancy test performed by study staff is required for inclusion; however a self-reported pregnancy is adequate for exclusion from the study.
• Diagnosed with urinary tract infection (UTI) at Screening or Enrollment Note: Otherwise eligible participants diagnosed with UTI during screening are offered treatment and may be enrolled after completing treatment and all symptoms have resolved.

If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled.

• Diagnosed with pelvic inflammatory disease, an STI or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines at Screening or Enrollment Note: Otherwise eligible participants diagnosed during screening with pelvic inflammatory disease or STI/RTI requiring treatment per CDC guidelines - other than asymptomatic bacterial vaginosis (BV) and asymptomatic candidiasis - are offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled. Genital warts requiring treatment also mus