The Safety and Effectiveness of 524W91

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996

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.

Condition Intervention Phase
HIV Infections
Drug: Emtricitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Single-Dose, Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 18
Detailed Description:

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.


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:


  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00002335

United States, California
ViRx Inc
San Francisco, California, United States, 94103
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided Identifier: NCT00002335     History of Changes
Other Study ID Numbers: 233A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents processed this record on March 26, 2015