The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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 can strengthen the ability of AIDS patients to control infections. This study will also determine how long after a single injection of IFN-G white blood cells remain stimulated. 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 transplants. These treatments include zidovudine (AZT), which has been shown to control the HIV infection, and IFN-G, a lymphokine which activates tumor-destroying and germ-killing functions. Studies are needed to find the dose by which IFN-G works best.
Key facts
- Study ID
- NCT00001112
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 5
- Expected to finish
- 1993-04-01
- Last updated by the study team
- 2021-11-04
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cornell University A2201 — New York, New York, United States
Full record on ClinicalTrials.gov
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