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

Completed

• Conditions: HIV
• Interventions: Procedure: Upper endoscopy; Procedure: Anoscopy; Drug: Truvada

• Registration Number: NCT02621242
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-10
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-03
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2023-03-30
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Results First Posted: 2024-07-12
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Truvada	All subjects will undergo all procedures
Cohort	Upper endoscopy	All subjects will undergo all procedures
Cohort	Anoscopy	All subjects will undergo all procedures

Primary Outcome Measures

Name	Time	Method
Global Transcriptome Analysis	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.

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States