A Study of 1592U89 in HIV-Infected Children

June 23, 2005 updated by: Glaxo Wellcome

1592U89 Open-Label Protocol for Pediatric Patients With HIV Infection.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Research Triangle Park, North Carolina, United States, 277093398
        • Glaxo Wellcome Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 238E
  • CNAA3007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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