Search / Trial NCT00002335

The Safety and Effectiveness of 524W91

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.

About Glaxo Wellcome

Glaxo Wellcome, a leading global biopharmaceutical company, is dedicated to advancing healthcare through innovative research and development of new therapies. With a strong focus on addressing unmet medical needs, Glaxo Wellcome combines scientific excellence with a commitment to improving patient outcomes across various therapeutic areas, including respiratory, infectious diseases, and oncology. The company is recognized for its robust clinical trial portfolio, leveraging cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. Glaxo Wellcome upholds the highest ethical standards in clinical research, ensuring patient safety and integrity throughout the trial process.

Locations

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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