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OpenTrials
Completed

NCT Number: NCT02621242

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Upper Endoscopy

Procedure

Upper endoscopy with biopsies

Anoscopy

Procedure

Anoscopy with biopsies

Truvada

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2015
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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