Status:
COMPLETED
A Study of Tumor Necrosis Factor and Human Interferon-gamma in Patients With AIDS Related Complex
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To study the tolerance and toxicity of the combination of tumor necrosis factor (TNF) and interferon gamma (IFN-G) or as single agent TNF or IFN-G in HIV infected patients. To selectively monitor the ...
Detailed Description
Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which causes AIDS and ARC in some laboratory studies, but may increase virus replication in other laboratory stu...
Eligibility Criteria
Inclusion Criteria
Patients who have a primary diagnosis of AIDS related complex (ARC) including lymphadenopathy syndrome (LAS), who are positive for HIV antibody, have a minimum life expectancy of 3 months, and have one or more of the following symptoms for = or > 30 days:
- Fever.
- Night sweats.
- Fatigue.
- Oral thrush.
- Hairy leukoplakia.
- Diarrhea.
- Weight loss < 10 percent.
- Patients must be able to sign a written informed consent form, which must be obtained prior to treatment.
Concurrent Medication:
Allowed:
- Acetaminophen for temperature rise of > 38.5 degrees C - 650 mg by mouth every 4 hours on an as needed basis.
Severe rigors may be treated (or prevented) with meperidine 50 mg IV on an as needed basis in the absence of systolic hypotension < 80 mm Hg.
-
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Clinically significant cardiac disease - New York Heart Association Class II, III, or IV.
- Hemorrhagic diathesis (including hemophilia) or active bleeding disorder (e.g., genitourinary, gastrointestinal).
- Clinically apparent vascular disease (including a prior history of pulmonary embolus, deep venous thrombosis, or peripheral arterial occlusive disease).
Concurrent Medication:
Excluded:
- Medications required for the treatment of active cardiac disease including cardiac glycosides, antiarrhythmics and antianginal agents.
- Anticoagulants.
- Thrombolytic agents.
- Nonsteroidal anti-inflammatory drugs.
- Ongoing therapy with vasodilators.
- Aspirin.
- Corticosteroids.
- Antihistamines.
- Barbiturates.
- Excluded within 4 weeks of study entry:
- Antiviral chemotherapy.
- Immunotherapy.
- Excluded within 12 weeks of study entry:
- Suramin.
Patients with the following are excluded:
- AIDS-associated opportunistic infection.
- Lipoprotein disorders.
- Hemophilia.
Prior Medication:
Excluded:
- Interferon gamma.
- Tumor necrosis factor.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 1990
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00001004
End Date
February 1 1990
Last Update
November 4 2021
Active Locations (1)
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1
Univ of Washington
Seattle, Washington, United States, 98105