Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/17/2018 |
| Start Date: | December 2015 |
| End Date: | December 2017 |
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.
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.
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.
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