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OpenTrials
Completed

NCT Number: NCT03218085

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Inflammation Vagina Lentivirus Infections Menopause Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vaginal Diseases Vaginitis Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tenofovir

Drug

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

Emtricitabine

Drug

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

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • American College of Clinical Pharmacy

Registry information

Official study title

Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2017
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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