A Study of 1592U89 in HIV-Infected Adults

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

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

Gender

ALL

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.