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The Safety and Effectiveness of 524W91
This study has been completed.
Study NCT00002335   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002335 on ClinicalTrials.gov Archive Site
 
 
 
The Safety and Effectiveness of 524W91
A Phase I, Randomized, Single-Dose, Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91

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 state.

Phase I
Interventional
Treatment, Placebo Control, Pharmacokinetics Study
HIV Infections
Drug: Emtricitabine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
18
 
 

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002335
 
233A
Glaxo Wellcome
 
 
NIH AIDS Clinical Trials Information Service
April 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP