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Role of exogenous and endogenous sex hormones on tenofovir and emtricitabine disposition in female genital tract

Status: Recruiting

This study aims to determine the role of menopause and exogenous hormone use in regulating antiretroviral disposition in the female genital tract.

I'm interested

Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• female, or transgender female with a cervix
• HIV- positive
• on a stable antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks before starting the study
Exclusion Criteria:

• currently pregnant, or previous pregnancy in the past 3 months, or breast feeding
• vaginal infection within 2 weeks before starting the study
• abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior starting the study
• use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to starting the study
Conditions:

Women's Health

Keywords:

HIV/AIDS, Inflammation Vagina, Menopause

Contact(s): Sandy Bowers - kraus012@umn.edu
Principal Investigator: Melanie Nicol
IRB Number: 1610M98383
System ID: 19440
See this study on ClinicalTrials.gov

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