A Study of MKC-442 in HIV-Positive Patients

Launched by TRIANGLE PHARMACEUTICALS · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from plasma, administration of at least 2 available antiviral agents by prescription may be given with MKC-422.
• Patients must have:
• • - HIV infection with HIV-1 RNA greater than or equal to 2,000 by Roche Amplicor method, within 30 days of entry.
• Prior Medication:
• Allowed:
• • Prior nucleoside reverse transcriptase and protease inhibitors.
• • Cytotoxic chemotherapy more than 30 days prior to entry.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort.
• • Inadequately controlled seizure disorder.
• • Acute and clinically significant medical event within 30 days of screening.
• • Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of the listed laboratory values.
• Prior Medication:
• Excluded:
• • Non-nucleoside reverse transcriptase inhibitor therapy.
• • Any unapproved experimental antiretroviral therapy.
• Prior Treatment:
• Excluded:
• • Radiation therapy within 30 days of entry, except to a local lesion.
• • Transfusion of blood or blood products within 21 days of screening.
• Risk Behavior:
• Excluded:
• • Active substance abuse that may interfere with compliance or protocol evaluations.