Clinical benefits and recovery of delayed-type hypersensitivity in patients with AIDS-related complex treated with IMREG-1 or placebo

• Published in: International journal of immunopharmacology Vol. 13; no. 7; p. 999
• Main Authors: Fiala, M, Cone, L A, Sayre, J W
• Format: Journal Article
• Language: English
• Published: England 1991
• Subjects: Adult; AIDS-Related Complex - complications; AIDS-Related Complex - immunology; AIDS-Related Complex - therapy; Double-Blind Method; Humans; Hypersensitivity, Delayed; Immunotherapy; Lymphokines - adverse effects; Lymphokines - therapeutic use; Male; Opportunistic Infections - prevention & control; Pneumonia, Pneumocystis - prevention & control; Sarcoma, Kaposi - prevention & control
• ISSN: 0192-0561
• DOI: 10.1016/0192-0561(91)90053-A

IMREG-1, an immunomodulatory biological therapeutic, was studied in a placebo-controlled, double-blind, six-month trial in 45 anergic patients with AIDS-related complex (ARC) and 4 with Kaposi's sarcoma, which was followed by compassionate IMREG-1 administration to all subjects. The IMREG-1 group had significantly less AIDS-defining events compared with the placebo group during the randomized trial (6.9 events per 100 person-years vs 43.7 events per 100 person-years, P = 0.018, relative risk 6.33) and the total observation period. Patients receiving IMREG-1 significantly improved their work performance. Nine (41%) of 22 patients in the IMREG-1 group, compared with one (14%) of seven in the placebo group, recovered cutaneous reactivity to tetanus toxoid. At the end of the six-month trial, CD4+ counts were 0.429 x 10(9)/l in the IMREG-1 group and 0.304 x 10(9)/l in the placebo group (P = 0.04). IMREG-1 is a promising therapeutic for HIV-infected patients with symptoms of ARC.