A Study of 1592U89 in HIV-Infected Children

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002197
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1998
  Purpose

The purpose of this study is to see if it is safe to give 1592U89 to children (aged 6 months until 14th birthday) with advanced HIV infection who have few treatment options available. The study also examines the effect 1592U89 has on the levels of HIV in the blood.


Condition Intervention
HIV Infections
Drug: Abacavir sulfate

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: 1592U89 Open-Label Protocol for Pediatric Patients With HIV Infection.

Resource links provided by NLM:


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

Estimated Enrollment: 250
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002197

Locations
United States, North Carolina
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, United States, 277093398
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002197     History of Changes
Other Study ID Numbers: 238E, CNAA3007
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:
HIV-1
CD4 Lymphocyte Count
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014