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Modifiers of Tenofovir in the Female Genital Tract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377608
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
MU-JHU CARE
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment
HIV/AIDS Contraception Drug: Tenofovir Disoproxil Fumarate Drug: Depo-Provera

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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

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

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




Primary Outcome Measures :
  1. Cervical Tissue Concentrations [ Time Frame: Day 1 ]
    Assess the influence of hormonal contraception on tenofovir concentrations in cervical tissues


Secondary Outcome Measures :
  1. Proinflammatory cytokines [ Time Frame: Day 1 ]
    To determine relationship between local inflammation and drug disposition in the female genital tract

  2. Gene expression of drug metabolizing enzymes and transporters [ Time Frame: Day 1 ]
    To assess the influence of hormonal contraception on the expression of drug metabolizing enzymes and transporters in cervical tissue

  3. Vaginal microbiome [ Time Frame: Day 1 ]
    To identify potential role of the vaginal microbiome in local drug disposition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women will be recruited from an existing cohort.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377608


Locations
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Uganda
MU-JHU Care Ltd
Kampala, Uganda
Sponsors and Collaborators
University of Minnesota
MU-JHU CARE
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03377608    
Other Study ID Numbers: STUDY00000171
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
tenofovir
microbiome
inflammation
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Medroxyprogesterone Acetate
Medroxyprogesterone
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic