NCT03218085Completed
Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract
Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine
Source: ClinicalTrials.gov · Last updated 16 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 28 (actual)
- First submitted
- 10 Jul 2017
- Start date
- 14 Jul 2017
- Primary completion date
- 15 Feb 2024
- Lead sponsor
- University of Minnesota
- Diseases
- HIV
- NCT number
- NCT03218085
What you commit to
- Study type: Observational
- Participants enrolled: 28
- From 14 Jul 2017 to the primary completion date, 15 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.