Contraception Clinical Trial
Official title:
Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera
Verified date | April 2018 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 2, 2018 |
Est. primary completion date | March 29, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Uganda | MU-JHU Care Ltd | Kampala |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute | MU-JHU CARE |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cervical Tissue Concentrations | Assess the influence of hormonal contraception on tenofovir concentrations in cervical tissues | Day 1 | |
Secondary | Proinflammatory cytokines | To determine relationship between local inflammation and drug disposition in the female genital tract | Day 1 | |
Secondary | Gene expression of drug metabolizing enzymes and transporters | To assess the influence of hormonal contraception on the expression of drug metabolizing enzymes and transporters in cervical tissue | Day 1 | |
Secondary | Vaginal microbiome | To identify potential role of the vaginal microbiome in local drug disposition | Day 1 |
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