The Safety and Effectiveness of 524W91
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Emtricitabine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
Official title: A Phase I, Randomized, Single-Dose, Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91
Study design: Treatment, Placebo Control, Pharmacokinetics Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
ViRx Inc, San Francisco, California 94103, United States
Additional Information
Last updated: June 23, 2005
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