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CompletedNCT03218085Updated Apr 16, 2024

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

An observational study in HIV/AIDS, Menopause and Inflammation Vagina, sponsored by University of Minnesota. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • HIV/AIDS
  • Menopause
  • Inflammation Vagina

Keywords

  • tenofovir
  • prevention
  • microbiome
  • cervicovaginal
  • biopsy
  • swab
  • cytokines
  • inflammation
  • pharmacology
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (actual)
Patient registry
No

Interventions

  • DrugTenofovir

    Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit

  • DrugEmtricitabine

    Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit

05

What researchers measure

Primary outcomes

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

    Time frame: Day 1

Secondary outcomes

  1. To assess the influence of endogenous and exogenous sex hormones on the expression of drug metabolizing enzymes and transporters in cervical tissue

    Time frame: Day 1

  2. To determine the influence of endogenous and exogenous sex hormones on the endogenous nucleotide pool in cervical tissues

    Time frame: Day 1

  3. To discriminate between local and systemic effects of hormonal use on antiretroviral disposition.

    Time frame: Day 1

  4. To determine relationship between local inflammation and drug disposition in the female genital tract

    Time frame: Day 1

  5. To identify potential role of the vaginal microbiome in local drug disposition,

    Time frame: Day 1

06

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
07

Registry details

Key details

Study ID
NCT03218085
Lead sponsor
University of Minnesota
Collaborators
American College of Clinical Pharmacy
Responsible party
Sponsor
First posted
Jul 14, 2017
Start date
Jul 14, 2017
Primary completion
Feb 15, 2024
Completion
Feb 15, 2024
Last update
Apr 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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