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A phase I study of subcutaneous recombinant interleukin-2 in patients with advanced HIV disease while on zidovudine.




 

AIDS. 1994 Jan;8(1):59-66. Unique Identifier : AIDSLINE MED/94280705

OBJECTIVE: A Phase I study of subcutaneous recombinant interleukin-2 (rIL-2). DESIGN: Sixteen patients with advanced HIV infection receiving 600-1200 mg zidovudine per day were divided into three groups, which received sequentially 0.2 x 10(6), 0.7 x 10(6) or 2 x 10(6) units/m2 per day of rIL-2 subcutaneously 5 consecutive days. SETTING: Five-day admission to an academic tertiary care hospital. PATIENTS, PARTICIPANTS: Sixteen unblinded, non-randomized volunteers. INTERVENTIONS: Subcutaneous rIL-2. MAIN OUTCOME MEASURES: Tolerance, toxicity, hematologic, immunologic and antiviral responses. RESULTS: rIL-2 was well-tolerated at the highest dosage, except in two patients who developed significant lymphopenia by the second day of rIL-2 administration, with rebound within 48 h after rIL-2 therapy. The number of eosinophils, CD4+ and CD8+ cells, and percentage of CD16+ (natural killer) cells, remained elevated above baseline for up to 10 weeks. Circulating rIL-2 receptor levels increased transiently during and immediately following rIL-2 administration. A twofold increase in natural killer cell activity against uninfected and HIV-infected targets was observed, but did not persist beyond 10 weeks following rIL-2 administration. There was a transient decrease in blastogenesis to phytohemagglutinin of patients receiving the highest dose of r-IL-2, but no significant change in viral burden. CONCLUSIONS: Subcutaneous rIL-2 in advanced HIV-infected patients on zidovudine was tolerated with side-effects similar to intravenous IL-2.

Adult Drug Therapy, Combination Human HIV Infections/*DRUG THERAPY/MICROBIOLOGY Injections, Subcutaneous Interleukin-2/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Killer Cells/DRUG EFFECTS/IMMUNOLOGY Leukocytes/DRUG EFFECTS Lymphocyte Transformation/DRUG EFFECTS/IMMUNOLOGY Male Middle Age Receptors, Interleukin-2/ANALYSIS Recombinant Proteins/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ THERAPEUTIC USE Support, U.S. Gov't, P.H.S. Zidovudine/*THERAPEUTIC USE CLINICAL TRIAL CLINICAL TRIAL, PHASE I JOURNAL ARTICLE



 




Information in this article was accurate in September 30, 1994. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.