Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract
NCT ID: NCT03218085
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
28 participants
OBSERVATIONAL
2017-07-14
2024-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Tenofovir
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
Emtricitabine
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
FEMALE
No
Sponsors
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American College of Clinical Pharmacy
OTHER
University of Minnesota
OTHER
Responsible Party
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Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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PHARM-2016-24820
Identifier Type: -
Identifier Source: org_study_id
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