Search / Trial NCT00002338

The Safety and Effectiveness of 935U83 in HIV-Infected Patients

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 (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Recommended:
  • PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation.
  • Allowed:
  • Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
  • Patients must have:
  • HIV infection.
  • CD4 count 200 - 500 cells/mm3.
  • No history of or current AIDS-defining indicator disease by CDC criteria.
  • No antiretroviral therapy within the past 6 months.
  • Consent of parent or guardian if less than 18 years of age.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patient with the following symptoms or conditions are excluded:
  • Current evidence of chronic hepatitis of any etiology.
  • Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.
  • Concurrent Medication:
  • Excluded:
  • Cytotoxic chemotherapy.
  • Other antiretroviral drugs.
  • Immunomodulators.
  • Foscarnet.
  • GM-CSF or G-CSF.
  • Erythropoietin.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • Patients with the following prior conditions are excluded:
  • History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years.
  • Prior Medication:
  • Excluded within the past 6 months:
  • Any antiretroviral therapy.
  • HIV immunotherapeutic vaccine.
  • Excluded within the past 4 weeks:
  • Cytotoxic chemotherapy.
  • Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon.
  • Prior Treatment:
  • Excluded within the past 4 weeks:
  • Radiation therapy. Current alcohol or illicit drug use that may interfere with study 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

Washington, District Of Columbia, United States

Durham, North Carolina, United States

Maitland, Florida, United States

San Francisco, California, United States

Cincinnati, Ohio, United States

Pittsburgh, Pennsylvania, United States

Indianapolis, Indiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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