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The Safety and Effectiveness of 524W91

Sponsor
Glaxo Wellcome (Industry)
Overall Status
Completed
CT.gov ID
NCT00002335
Collaborator
(none)
18
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase I, Randomized, Single-Dose, Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ViRx Inc San Francisco California United States 94103

    Sponsors and Collaborators

    • Glaxo Wellcome

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002335
    Other Study ID Numbers:
    • 233A
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Apr 1, 1996
    Keywords provided by , ,
    Acquired Immunodeficiency Syndrome
    AIDS-Related Complex
    Antiviral Agents
    Additional relevant MeSH terms:
    HIV Infections
    Emtricitabine

    Study Results

    No Results Posted as of Jun 24, 2005