Status:
COMPLETED
Modifiers of Tenofovir in the Female Genital Tract
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
MU-JHU CARE
Conditions:
HIV/AIDS
Contraception
Eligibility:
FEMALE
18-35 years
Brief Summary
Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.
Eligibility Criteria
Inclusion
- Female, or transgender female with a cervix, aged 18-35 years old
- HIV-positive
- Stable on antiretroviral regimen containing TDF 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.
Exclusion
- Currently pregnant or previous pregnancy within 3 months of enrollment
- Currently breast feeding
- Symptomatic vaginal infection within 2 weeks prior to enrollment
- Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
- History of vulvar/vaginal/ cervical dysplasia, neoplasia or cancer, atypical squamous cells of undetermined significance, condyloma, or human papilloma virus (HPV) in the past year
- Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit
Key Trial Info
Start Date :
November 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 2 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03377608
Start Date
November 17 2017
End Date
April 2 2018
Last Update
May 1 2018
Active Locations (1)
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1
MU-JHU Care Ltd
Kampala, Uganda