NCT00002197

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 1998

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1CD4 Lymphocyte CountReverse Transcriptase InhibitorsAnti-HIV AgentsViral Loadabacavir

Interventions

Abacavir sulfateDRUG

Eligibility Criteria

Age6 Months - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaxo Wellcome Inc

Research Triangle Park, North Carolina, 277093398, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1998-12

Locations

US(1)