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The Safety and Effectiveness of 524W91



The Safety and Effectiveness of 524W91

For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Placebo Control, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 18

Location and Contact Information:

ViRx Inc
San Francisco,  California,  94103
United States
 


Additional Information:
Study ID Numbers:  233A; 
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002335

Other Hiv Infections Studies:
1. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B

2. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

3. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia

4. Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection

5. Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma

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