A Study of 1592U89 in HIV-Infected Adults

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002200

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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