N/A
N=9
Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02621242 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Global Transcriptome Analysis — 116; 135 genes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Upper endoscopy (Procedure); Anoscopy (Procedure); Truvada (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Washington
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Transcriptome Analysis |
116; 135 | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT02621242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.