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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621242
• Other study ID #: 49167
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Procedure:
• Upper endoscopy
Upper endoscopy with biopsies
• Anoscopy
Anoscopy with biopsies

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

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-10 (IL-10) and mitochondrially encoded ATP synthase 6 (MT-ATP6) mRNA copy numbers.	Copy numbers per 1000 copies of the housekeeping gene hemoglobin B (HBB) (copies / 1000 HBB copies)	2-3 months after initiating HIV Pre-exposure prophylaxis
Primary	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