Clinical trial NCT03218085: Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract
Official title: Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Menopause
Inflammation Vagina
Keywords: tenofovir
prevention
microbiome
cervicovaginal
biopsy
swab
cytokines
inflammation
pharmacology
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: American College of Clinical Pharmacy
First posted: 2017-07-14
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Currently pregnant or previous pregnancy within 3 months of enrollment
2. Currently breast feeding
3. Symptomatic vaginal infection within 2 weeks prior to enrollment
4. Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
5. Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues
timeFrame: Day 1
Secondary outcomes:
measure: To assess the influence of endogenous and exogenous sex hormones on the expression of drug metabolizing enzymes and transporters in cervical tissue
timeFrame: Day 1
measure: To determine the influence of endogenous and exogenous sex hormones on the endogenous nucleotide pool in cervical tissues
timeFrame: Day 1
measure: To discriminate between local and systemic effects of hormonal use on antiretroviral disposition.
timeFrame: Day 1
measure: To determine relationship between local inflammation and drug disposition in the female genital tract
timeFrame: Day 1
measure: To identify potential role of the vaginal microbiome in local drug disposition,
timeFrame: Day 1
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: