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A Study of 1592U89 in HIV-Infected Adults

This study has been completed.
Study NCT00002200.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  A Study of 1592U89 in HIV-Infected Adults
Official Title  A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.
Brief Summary

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.

Detailed Description

Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.

Study Phase
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Abacavir sulfate
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

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.

Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002200
Organization ID 238M
Secondary IDs †† CNAA3008
Study Sponsor  Glaxo Wellcome
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date December 1998
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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