The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

AIDS is a disease that progressively destroys that aspect of the body's defense called the immune system. It is particularly harmful to a class of cells called helper T-lymphocytes. The specific opportunistic infections and malignancies associated with AIDS have been treated with therapies that are often poorly tolerated by the patients and are associated with dose-limiting toxicities. The principal focus of AIDS therapy research at present is to control the underlying retroviral infection and to restore immune function with recombinant lymphokines, adoptive immunotherapy, and/or lymphocyte...

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ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Prophylactic antibiotics.
• • Tylenol (650 mg orally every 6 hours as needed for temperature \> 38.5 degrees C).
• • Meperidine (25 - 50 mg intravenously, once, for severe rigors if systolic blood pressure is \> 90 mmHg).
• • Patients must meet criteria for AIDS classification (CDC) category IV C-1.
• • Patients must have had one or more prior opportunistic infections identified in surveillance definition of AIDS. Patients whose AIDS-defining illness is Kaposi's sarcoma are also eligible if they have previously had one of the secondary infectious diseases identified in category C-1.
• Prior Medication:
• Required:
• • Patients must have been receiving zidovudine (AZT) on a stable dosage regimen for at least 8 weeks immediately preceding entry into study.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following are excluded:
• • Clinically significant cardiac (= or \> class II, New York Heart Association) or peripheral vascular disease that requires treatment.
• • Presence of an active opportunistic infection that requires treatment.
• • Hemorrhagic diathesis or active bleeding disorder.
• • Clinically apparent vascular disease.
• Concurrent Medication:
• Excluded:
• • Medications required for treatment of active cardiac disease.
• • Ongoing therapy with anticoagulants or thrombolytic agents.
• Patients with the following are excluded:
• • Clinically significant cardiac (= or \> class II, New York Heart Association) or peripheral vascular disease that requires treatment.
• • Presence of an active opportunistic infection that requires treatment.
• • Hemorrhagic diathesis or active bleeding disorder.
• • Clinically apparent vascular disease.
• Prior Medication:
• Excluded within 4 weeks of study entry:
• • Antiviral chemotherapy other than zidovudine.
• * Excluded within 12 weeks of study entry:
• • Immunosuppressive or cytotoxic therapy.