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.
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
Patients must have:
- Documented HIV infection.
- CD4 count >= 200 cells/mm3.
- No active opportunistic infection.
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.
Excluded on the day of each dose:
- 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.
- 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.