Modifiers of Tenofovir in the Female Genital Tract

Completed

• Conditions: HIV/AIDS; Contraception
• Interventions: Drug: Tenofovir Disoproxil Fumarate; Drug: Depo-Provera

• Registration Number: NCT03377608
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-17
• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-19
• Primary Completion: 2018-03-29
• Status Verified: 2018-04
• Study Completion: 2018-04-02
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Depo-Provera	Depo-Provera	-
Non-hormonal contraception	Tenofovir Disoproxil Fumarate	-
Depo-Provera	Tenofovir Disoproxil Fumarate	-

Primary Outcome Measures

Name	Time	Method
Cervical Tissue Concentrations	Day 1	Assess the influence of hormonal contraception on tenofovir concentrations in cervical tissues

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MU-JHU Care Ltd; 🇺🇬 Kampala, Uganda