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

NCT02621242 | Completed Results

• 1 other identifier: 49167
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Global Transcriptome Analysis

  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.

  2-3 months after initiating HIV Pre-exposure prophylaxis

Study Arms (1)

Cohort

All subjects will undergo all procedures

Procedure: Upper endoscopy; Procedure: Anoscopy; Drug: Truvada

Interventions

Upper endoscopy PROCEDURE

Upper endoscopy with biopsies

Cohort

Anoscopy PROCEDURE

Anoscopy with biopsies

Cohort

Truvada DRUG

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

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is a prospective observational study of cis-gender male persons initiating HIV pre-exposure prophylaxis.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Gastroscopy; Proctoscopy; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Joanne Stekler
• Organization: University of Washington

jstekler@uw.edu

206-744-8312

Study Officials

• Joanne Stekler, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Allergy & Infectious Diseases

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: December 3, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-01

Locations

US (1)