CompletedNot Applicable

Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract

United States28 participantsStarted 2017-07-14

Plain-language summary

Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Female, or transgender female with a cervix, age 18 years or older
✓. HIV-positive
✓. Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment.
✓. Virally suppressed (HIV-RNA copies \<50 copies/mL) for at least 6 months at time of enrollment.
✓. Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
✓. Willing and able to give signed informed consent.

What they're measuring

Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues

Timeframe: Day 1

Trial details

NCT IDNCT03218085

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-15

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