Phase I/II trial of soluble recombinant human interleukin-1 receptor (rhu IL-1R) in patients with human immunodeficiency virus-1 (HIV-1) infection (Meeting abstract).

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

Phase I/II trial of soluble recombinant human interleukin-1 receptor (rhu IL-1R) in patients with human immunodeficiency virus-1 (HIV-1) infection (Meeting abstract).

Proc Annu Meet Am Assoc Cancer Res; 14:A834 1995. Unique Identifier : AIDSLINE ICDB/95613986
Krown SE; Paredes J; Polsky B; Pino MC; Agosti J; Memorial Sloan-Kettering Cancer Center, New York, NY

Abstract: Elevated serum levels of IL-1, a proinflammatory, proangiogenic cytokine, have been described in HIV-1+ individuals. IL-1 upregulates HIV expression and stimulates growth of Kaposi's sarcoma (KS) spindle cells in vitro. Biologic activities are mediated via the type I IL-1R. Soluble rhu IL-1R, the extracellular, IL-1 binding region of the receptor, has a binding affinity indistinguishable from membrane-bound IL-1R. We conducted a phase I/II trial to assess safety and activity of rhu IL-1R in HIV-1+ individuals with CD4 less than or equal to 300 cells/mm3. Patients (pts) enrolled at 125 (n = 3), 500 (n = 3) and 1250 (n = 7) ug/m2/dose and were treated SC 3x/wk for 8 wk, followed by a 4 wk observation period. At 1250 ug, 1 pt withdrew voluntarily after less than 2 wk, 1 developed an intercurrent illness (peripheral nerve palsy) in wk 8 and refused follow up and 2 pts remain on study at 2 and 6 wk. No side effects attributable to rhu IL-1R were noted. Seven pts reported improvements in greater than or equal to 1 symptom including increased weight (3) and energy level (4), decreased diarrhea (1) and night sweats (1), and improvement in psoriatic arthritis (1). Of 3 evaluable pts with KS, 1 remained stable and 2 showed minimal progression. Thus far we observe no consistent trends in CD4 counts, quantitative HIV cultures, or serum p24 antigen, beta-2-microglobulin or triglyceride levels. We conclude that rhu IL-1R is safe and well tolerated at the doses tested, but induced no consistent changes in objective markers of HIV disease. Symptomatic improvement will require confirmation in randomized, placebo-controlled trials.

Keywords: Acquired Immunodeficiency Syndrome/IMMUNOLOGY/*THERAPY CD4 Lymphocyte Count Human HIV Infections/IMMUNOLOGY/*THERAPY HIV Seropositivity/IMMUNOLOGY/*THERAPY *Receptors, Interleukin-1 Recombinant Proteins/*TOXICITY/*THERAPEUTIC USE ABSTRACT CLINICAL TRIAL CLINICAL TRIAL, PHASE I CLINICAL TRIAL, PHASE II
951230
M95C3220

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