Search / Trial NCT00002197

A Study of 1592U89 in HIV-Infected Children

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Hiv 1 Cd4 Lymphocyte Count Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load Abacavir

ClinConnect Summary

This is an open-label, non-randomized study. All patients will be treated with 1592U89. Additionally, since optimal therapy usually includes the combined use of 2 or more antiretroviral agents in advanced patients, other novel antiretroviral therapies may be accessed through commercial means or via compassionate use programs. NOTE: 1592U89 should not be administered as a single new agent added to a failing treatment regimen.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Intravenous immunoglobulin G.
  • Erythropoietin, granulocyte colony stimulating factor and granulocyte macrophage colony stimulating factor, for the management of hematologic toxicity.
  • Patients must have:
  • Documented HIV infection.
  • * High risk for disease progression or mortality as defined by either of the following:
  • Viral load \> 100,000 copies/ml and CD4 cells \< 15% of total lymphocyte count despite at least 4 weeks of therapy with commercially available antiretrovirals or as a result of no therapy due to treatment-limiting toxicity of ZDV, 3TC, and ddI; or HIV-associated encephalopathy refractory to ZDV-containing regimen.
  • No access to any 1592U89 pediatric study where the patient could qualify for inclusion.
  • Parent or legal guardian with the ability to understand and provide written consent for the patient to participate in the trial. Study patients over 13 years should also give written informed consent whenever possible.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with any of the following symptoms or conditions are excluded:
  • In the investigator's opinion, the patient is unlikely to comply with the requirements of the study.
  • Renal failure requiring dialysis.
  • Hepatic failure evident by Grade 3 or 4 hyperbilirubinemia and AST \> 10 X upper limits of normal.
  • Life-threatening infection or other chronic disease that may interfere with taking 1592U89 or compromise the patient's safety.
  • Patients with the following prior conditions are excluded:
  • Documented hypersensitivity to 1592U89 or any other nucleoside analogue.
  • See Inclusion - General Criteria.

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

Research Triangle Park, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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