Research Triangle Park,
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.
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
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
- Participation in or ability to participate in an enrolling study of 1592U89.
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.