A phase I/II study of recombinant tumor necrosis factor and recombinant interferon gamma in patients with AIDS-related complex.

Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.

A phase I/II study of recombinant tumor necrosis factor and recombinant interferon gamma in patients with AIDS-related complex.

Biotechnol Ther. 1989-90;1(3):229-36. Unique Identifier : AIDSLINE MED/93160946
Kaplan LD; Abrams DI; Sherwin SA; Kahn J; Volberding PA; Department of Medicine, San Francisco General Hospital,; California 94110.

Abstract: A clinical trial was conducted to determine the tolerance and toxicity of recombinant tumor necrosis factor (rTNF) and recombinant interferon gamma (rIFN-gamma) when administered concurrently by continuous intravenous infusion to 11 patients with the AIDS-related complex (ARC). In addition, HIV culture, p24 antigen levels, and CD4 positive lymphocytes were monitored to obtain preliminary evidence of antiviral and immunologic effects. Two 5-day treatment cycles were separated by a 9-day washout period. Two patients were entered at each dosage level and each patient received the two 5-day treatment cycles at two sequential dose levels ranging from 1 to 25 micrograms/m2. Two patients did not complete their second treatment cycle--one due to the development of a rash, the second due to central venous catheter discomfort. The occurrence of phlebitis with peripheral vein administration of these agents necessitated administration via central venous catheter. With the exception of a single patient who developed severe headache at the 25 micrograms/m2 dose, severe clinical toxicities were not observed. Fever, chills, headache, and myalgias were the most significant clinical toxicities observed and all were dose dependent. The percentage fall in total granulocytes was dose dependent and ranged from 17% at the 1 microgram/mm2 dose to 48% at both the 15 and 25 micrograms/mm2 dose levels. The mean nadir granulocyte count was 1694/mm3. No significant renal or hepatic toxicity was observed. Of 22 treatment cycles the CD4 cell number was increased in 11, unchanged in 7, and decreased in 4. The mean CD4 cell number did not change significantly (176 +/- 143/mm3 pretherapy versus 279 +/- 305/mm3 posttherapy).(ABSTRACT TRUNCATED AT 250 WORDS)

Keywords: Adult Antiviral Agents/ADVERSE EFFECTS/*THERAPEUTIC USE AIDS-Related Complex/*THERAPY Human Interferon-gamma, Recombinant/ADVERSE EFFECTS/*THERAPEUTIC USE Male Recombinant Proteins/ADVERSE EFFECTS/THERAPEUTIC USE Support, Non-U.S. Gov't Tumor Necrosis Factor/ADVERSE EFFECTS/*THERAPEUTIC USE CLINICAL TRIAL CLINICAL TRIAL, PHASE I CLINICAL TRIAL, PHASE II JOURNAL ARTICLE
930530
M9350985

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