In vitro and in vivo activation of human mononuclear phagocytes by interferon-gamma. Studies with normal and AIDS monocytes.
H W Murray, D Scavuzzo, J L Jacobs...
https://pubmed.ncbi.nlm.nih.gov/3104467Completed
Phase 1
Age: 18Years - 65Years
All Genders
ID00001112
A Phase I Study To Determine the Safety of the Optimal Monocyte Activating Administration Schedule of Subcutaneous Human Recombinant Interferon-gamma in ZDV-Treated Patients With AIDS
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
5
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
Cornell University A2201
New York, New York, United States, 10021
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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