A Randomized Multicenter Phase II Trial of Recombinant Tumor Necrosis Factor and Recombinant Human Interferon-gamma in Patients With AIDS Related Complex

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.