HIV/AIDS, Contraception
Conditions
Keywords
tenofovir, microbiome, inflammation
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.
Interventions
DRUGTenofovir Disoproxil Fumarate
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
DRUGDepo-Provera
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
Sponsors
MU-JHU CARE
University of Minnesota
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Tissue Concentrations | Day 1 | Assess the influence of hormonal contraception on tenofovir concentrations in cervical tissues |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proinflammatory cytokines | Day 1 | To determine relationship between local inflammation and drug disposition in the female genital tract |
| Gene expression of drug metabolizing enzymes and transporters | Day 1 | To assess the influence of hormonal contraception on the expression of drug metabolizing enzymes and transporters in cervical tissue |
| Vaginal microbiome | Day 1 | To identify potential role of the vaginal microbiome in local drug disposition |
Countries
Uganda
Outcome results
None listed