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

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 I

Study Type: Interventional
Study Design: Treatment, Placebo Control, Pharmacokinetics Study
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002335

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

No publications provided

Study ID Numbers: 233A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002335     History of Changes
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

Study placed in the following topic categories:
Virus Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Emtricitabine
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
2',3'-dideoxy-5-fluoro-3'-thiacytidine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Emtricitabine
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 02, 2009