A Comparison of 141W94 and Indinavir in HIV-Infected Patients

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

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Gender

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Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Documented HIV infection.
• • HIV RNA \>= 400 copies/ml within 14 days prior to randomized study drug administration.
• • No active AIDS-defining opportunistic infection or disease.
• • Signed, informed consent from parent or legal guardian of patients less than 18 years of age.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Unlikely to complete the randomized dosing period.
• • Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or ability to take oral medications.
• • Serious medical conditions (e.g., diabetes, cardiac dysfunction, hepatitis) that would compromise patient safety.
• Concurrent Medication:
• Excluded:
• • Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
• • Investigational treatments (treatment through Treatment IND or expanded-access programs are evaluated individually).
• • Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons.
• • Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine-containing regimens.
• Concurrent Treatment:
• Excluded:
• • Radiation therapy (except local treatment for Kaposi's sarcoma).
• Patients with the following prior conditions are excluded:
• • Clinically relevant pancreatitis or hepatitis within the last 6 months.
• Prior Medication:
• Excluded:
• • Cytotoxic chemotherapeutic agents within 30 days of study drug administration (except local treatment for Kaposi's sarcoma).
• • Protease inhibitor therapy.
• • Dose of vaccine through an investigational HIV vaccine trial within the 3 months prior to study drug administration.
• • Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons within 30 days of study drug administration.
• Prior Treatment:
• Excluded:
• • Radiation therapy within 30 days prior to study drug administration (except local treatment for Kaposi's sarcoma).
• Risk Behavior:
• Excluded:
• • Current alcohol or illicit drug use that may interfere with drug absorption or ability to take oral medication.
• Required:
• • NRTI therapy at day of entry and up to screening.
• Required:
• • \>= 12 weeks of NRTI therapy.