Status:
COMPLETED
The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
To find out which of four doses of (recombinant) human interferon gamma (IFN-G) is most effective in stimulating the white blood cells (monocytes) to fight infection and to see if treatment with IFN-G...
Detailed Description
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 oppor...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1993
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00001112
End Date
April 1 1993
Last Update
November 4 2021
Active Locations (1)
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1
Cornell University A2201
New York, New York, United States, 10021