Search / Trial NCT00002388

A Study of 1592U89 in HIV-Infected Patients

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Hiv 1 Reverse Transcriptase Inhibitors Anti Hiv Agents

Description

Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase. On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Prophylaxis for opportunistic infections.
  • Patients must have:
  • * HIV-1 infection.
  • * CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.
  • * No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions and symptoms are excluded:
  • * Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
  • * Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.
  • Concurrent Medication:
  • Excluded:
  • * Immunomodulating agents.
  • * Chemotherapeutic agents.
  • * Antiretroviral therapy. NOTE:
  • * Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • Patients with the following prior conditions are excluded:
  • * History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
  • * History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.
  • Prior Medication:
  • Excluded:
  • * Treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
  • * Antiretroviral therapy within 2 weeks prior to administration of study drugs.
  • Prior Treatment:
  • Excluded:
  • Radiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study.

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

Evanston, Illinois, United States

Boston, Massachusetts, United States

Albany, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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