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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT01106586

HIV HIV Infections

COMPLETED PHASE3

Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

NCT01108510

HIV HIV Infections

COMPLETED PHASE3

Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection

NCT00959894

HIV Infections

COMPLETED PHASE2

Single Dose Truvada in HIV-negative Men and Women

NCT01326221

Pharmacokinetic Study in Healthy Volunteers

COMPLETED

A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA

NCT01865799

Pre-exposure Prophylaxis for Prevention of HIV Infection

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort

All subjects will undergo all procedures

Upper endoscopy

Intervention Type PROCEDURE

Upper endoscopy with biopsies

Anoscopy

Intervention Type PROCEDURE

Anoscopy with biopsies

Truvada

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Upper endoscopy

Upper endoscopy with biopsies

Intervention Type PROCEDURE

Anoscopy

Anoscopy with biopsies

Intervention Type PROCEDURE

Truvada

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes