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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03377608
Other study ID # STUDY00000171
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 17, 2017
Est. completion date April 2, 2018

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tenofovir Disoproxil Fumarate
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
Depo-Provera
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit

Locations

Country Name City State
Uganda MU-JHU Care Ltd Kampala

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute MU-JHU CARE

Country where clinical trial is conducted

Uganda, 

Outcome

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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