The Safety and Effectiveness of 524W91

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Emtricitabine

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.