Modifiers of Tenofovir in the Female Genital Tract

NCT03377608 | Completed FDA Drug

• 1 other identifier: STUDY00000171
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Contraception

Keywords

tenofovir; microbiome; inflammation

Outcome Measures

Primary Outcomes (1)

• Cervical Tissue Concentrations

  Assess the influence of hormonal contraception on tenofovir concentrations in cervical tissues

  Day 1

Secondary Outcomes (3)

• Proinflammatory cytokines

  Day 1

• Gene expression of drug metabolizing enzymes and transporters

  Day 1

• Vaginal microbiome

  Day 1

Study Arms (2)

Depo-Provera

Drug: Tenofovir Disoproxil Fumarate; Drug: Depo-Provera

Non-hormonal contraception

Drug: Tenofovir Disoproxil Fumarate

Interventions

Tenofovir Disoproxil Fumarate DRUG

Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit

Depo-Provera; Non-hormonal contraception

Depo-Provera DRUG

Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit

Depo-Provera

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women will be recruited from an existing cohort.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• MU-JHU CARE: collaborator

Study Sites (1)

MU-JHU Care Ltd

Kampala, Uganda

Location

Related Publications (1)

• Nicol MR, Eneh P, Nakalega R, Kaiser T, Kabwigu S, Isingel E, Beksinska M, Sykes C, Fowler MG, Brown TT, Staley C, Kiweewa Matovu F. Depot Medroxyprogesterone Acetate and the Vaginal Microbiome as Modifiers of Tenofovir Diphosphate and Lamivudine Triphosphate Concentrations in the Female Genital Tract of Ugandan Women: Implications for Tenofovir Disoproxil Fumarate/Lamivudine in Preexposure Prophylaxis. Clin Infect Dis. 2020 Apr 10;70(8):1717-1724. doi: 10.1093/cid/ciz443.

  PMID: 31131846 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Inflammation

Interventions

Tenofovir; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 19, 2017
• Study Start: November 17, 2017
• Primary Completion: March 29, 2018
• Study Completion: April 2, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)