Modifiers of Tenofovir in the Female Genital Tract

Contraception Clinical Trial

Official title:

Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377608
• Other study ID #: STUDY00000171
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Contraception
• HIV/AIDS

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