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A Study of 1592U89 in HIV-Infected Adults

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002200
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1998
November 2, 1999
June 23, 2005
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No Changes Posted
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A Study of 1592U89 in HIV-Infected Adults
A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.
The purpose of this study is to see if it is safe and effective to give 1592U89 to HIV-positive adults. This study also examines the influence previous anti-HIV treatment has on the effectiveness of 1592U89.
Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.
Interventional
Not Provided
Primary Purpose: Treatment
HIV Infections
Drug: Abacavir sulfate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria

Concurrent Medication:

Allowed:

Erythropoietin, G-CSF and GM-CSF.

Patients must have:

  • CD4+ cell count < 100 cells/mm3.
  • HIV-1 RNA > 30,000 copies/ml.
  • Signed, informed consent from parent or legal guardian for patient under 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Renal failure requiring dialysis.
  • Hepatic failure evident by grade 3/4 hyperbilirubinemia and AST 5 times the upper limit of normal.
  • Documented hypersensitivity to 1592U89.
  • Serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient.
  • Participation in or ability to participate in an enrolling study of 1592U89.

Required:

At least 2 nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (or intolerance to one protease inhibitor and one NRTI due to trying at least 2 different regimens with at least one protease inhibitor).

Alcohol or illicit drug use that may interfere with the patient's compliance.

Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002200
238M
CNAA3008
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
December 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP