Modifiers of Tenofovir in the Female Genital Tract

University of Minnesota (UMN)

Status: Completed

Conditions: Contraception; HIV/AIDS

Treatments: Drug: Depo-Provera; Drug: Tenofovir Disoproxil Fumarate

Study type: Observational

Funder types: Other

Identifiers

NCT03377608

STUDY00000171

Details and patient eligibility

About

Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Depo-Provera

Treatment:

Drug: Depo-Provera

Drug: Tenofovir Disoproxil Fumarate

Non-hormonal contraception

Treatment:

Drug: Tenofovir Disoproxil Fumarate