Modifiers of Tenofovir in the Female Genital Tract

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03377608
• Date of registration: 08/12/2017
• Prospective Registration: No
• Primary sponsor: University of Minnesota
• Public title: Modifiers of Tenofovir in the Female Genital Tract
• Scientific title: Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera
• Date of first enrolment: November 17, 2017
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03377608
• Study type: Observational

Countries of recruitment

Uganda

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

HIV/AIDS

Contraception

Intervention(s)

Drug: Depo-Provera

Drug: Tenofovir Disoproxil Fumarate

Primary Outcome(s)

Cervical Tissue Concentrations [Time Frame: Day 1]

Secondary Outcome(s)

Proinflammatory cytokines [Time Frame: Day 1]

Gene expression of drug metabolizing enzymes and transporters [Time Frame: Day 1]

Vaginal microbiome [Time Frame: Day 1]

Secondary ID(s)

STUDY00000171

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MU-JHU CARE