Research Triangle Park, North Carolina 27709

  • HIV Infections


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.

Study summary:

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


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.



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Location Contact:

Research Triangle Park, North Carolina 27709
United States

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Site Status: N/A

Data Source:

Date Processed: March 26, 2020

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