The Safety and Effectiveness of 524W91

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients. To determine the effects of food on bioavailability of 524W91.

Detailed Description

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

Patients are randomized to receive six single escalating doses of 524W91 or placebo, with each dose separated by at least a 6-day washout interval. In the time between 2 of the doses, the effect of food on pharmacokinetics will be investigated, with one dose administered in conjunction with a high-fat meal and one dose administered in a fasted state.

Conditions

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

HIV Infections

Study Design

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

Primary Study Purpose

TREATMENT

Interventions

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

Emtricitabine

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 count \>= 200 cells/mm3.
* No active opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malignancy or other condition that would confound study assessment or interfere with ability to complete the study.
* Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with gastrointestinal absorption.

Concurrent Medication:

Excluded on the day of each dose:

* Antiretrovirals.
* Any prescription or over-the-counter medication.
* Alcoholic beverages.
* Coffee, tea, and other xanthine-containing beverages and foods.

Patients with the following prior conditions are excluded:

History of hepatitis, pancreatitis, or cardiomyopathy within the past 5 years.

Prior Medication:

Excluded:

* Antiretrovirals within 24 hours prior to each dose.
* Any prescription or over-the-counter medications within 48 hours prior to each dose.
* Alcoholic beverages within 48 hours prior to each dose. Current alcohol or illicit drug use that may affect patient compliance.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ViRx Inc

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

233A

Identifier Type: -

Identifier Source: org_study_id