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

University of Washington

Status

Completed

Conditions

HIV

Treatments

Drug: Truvada

Procedure: Anoscopy

Procedure: Upper endoscopy

Study type

Observational

Funder types

Other

Identifiers

NCT02621242

49167

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.