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



Status:Recruiting
Conditions:HIV / AIDS, Women's Studies
Therapuetic Areas:Immunology / Infectious Diseases, Reproductive
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:July 14, 2017
End Date:December 31, 2020
Contact:Melanie Nicol, PharmD, PhD
Email:mrnicol@umn.edu
Phone:612-301-9511

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Trial Summary
Trial Overview
Inclusion Criteria

Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine

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.


Inclusion Criteria:

1. Female, or transgender female with a cervix, age 18 years or older

2. HIV-positive

3. Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2
weeks at time of enrollment.

4. Virally suppressed (HIV-RNA copies <50 copies/mL) for at least 6 months at time of
enrollment.

5. Willing to refrain from vaginal intercourse and use of vaginal devices such as douches
and sex toys within 72 hours of the biopsy visit.

6. Willing and able to give signed informed consent.
We found this trial at
1
site
University of Minnesota-Clinical and Translational Sciences Institute
Minneapolis, Minnesota 55455
Principal Investigator: Melanie Nicol, PharmD, PhD
Phone: 612-626-2750
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from
Minneapolis, MN
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