The Safety and Effectiveness of 524W91
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002335
- Run by
- Glaxo Wellcome
- People needed
- 18
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- Documented HIV infection.
- CD4 count >= 200 cells/mm3.
- No active opportunistic infection.
You may not qualify if…
- 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.
Where it is running
- ViRx Inc — San Francisco, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.