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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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Complete list of historical versions of study NCT00002200 on ClinicalTrials.gov Archive Site
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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
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Endpoint Classification: Safety Study
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.

Both
13 Years and older
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