Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Hladik
Previous Study | Return to List | Next Study

Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals

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: NCT02621242
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Joanne Stekler, University of Washington

Brief Summary:
As explained in detail in a recently published hypothesis article (Hladik F. A new hypothesis on HIV cure. F1000Research, 4:77 (2015)), the investigators hypothesize that NRTI drugs may reduce the likelihood of HIV eradication by promoting the survival of cells with integrated provirus. In this study, the investigators will test whether daily oral use of two NTRI drugs, tenofovir and emtricitabine (Truvada Pill), induces changes in the upper and lower gut mucosa that are congruent with supporting this hypothesis.

Condition or disease Intervention/treatment Phase
HIV Procedure: Upper endoscopy Procedure: Anoscopy Drug: Truvada Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals
Study Start Date : December 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Truvada

Arm Intervention/treatment
Cohort
All subjects will undergo all procedures
Procedure: Upper endoscopy
Upper endoscopy with biopsies

Procedure: Anoscopy
Anoscopy with biopsies

Drug: Truvada
Truvada (tenofovir/emtricitabine) daily as HIV pre-exposure prophylaxis. This medication will not be provided by the study.




Primary Outcome Measures :
  1. Interleukin-10 (IL-10) and mitochondrially encoded ATP synthase 6 (MT-ATP6) mRNA copy numbers. [ Time Frame: 2-3 months after initiating HIV Pre-exposure prophylaxis ]
    Copy numbers per 1000 copies of the housekeeping gene hemoglobin B (HBB) (copies / 1000 HBB copies)

  2. Global transcriptome analysis [ Time Frame: 2-3 months after initiating HIV Pre-exposure prophylaxis ]
    Global transcriptome analysis tests for expression changes of any possible gene across the entire human genome in response to Truvada PrEP. The main outcome of such an analysis is the number of genes significantly changing in expression between before and after treatment. We will report that Truvada PrEP up-regulates X number of genes and down-regulates Y number of genes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • HIV-negative

    • Male gender at birth
    • Age ≥18 years old
    • Intent to initiate PrEP in the next 1-2 months.
    • Willingness and ability to provide informed consent for study participation
    • Willingness to undergo all required study procedures

Exclusion Criteria:

  • Creatinine clearance < 60mL/min
  • Platelet count below the normal reference
  • Coagulation (PT/PTT) tests above the normal reference
  • Any prior use of PrEP
  • Use of PEP within 30 days prior to study entry
  • Receipt of

    • anti-coagulant medications (e.g. warfarin). Aspirin is allowable.
    • Systemic corticosteroid medications
    • Non-steroidal anti-inflammatory drug (NSAID) use >2 days/week
  • Signs or symptoms of acute HIV infection within 14 days of study entry
  • No availability of another person who will drive participant home on days of entry and follow-up procedures.
  • Plan to leave the Seattle area in the subsequent 2.5 months
  • Any condition or substance use that, in the opinion of the study investigator, would interfere with study participation.

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): NCT02621242


Locations
Layout table for location information
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Layout table for investigator information
Principal Investigator: Joanne Stekler, MD University of Washington

Layout table for additonal information
Responsible Party: Joanne Stekler, Associate Professor, Division of Allergy & Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier: NCT02621242     History of Changes
Other Study ID Numbers: 49167
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents