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Response to Treatment with the Leukocyte-derived Immunomodulator IMREG-1 in Immunocompromised Patients with AIDS-related Complex: A Multicenter, Double-Blind, Placebo-Controlled Trial

Marise S. Gottlieb, MD; Robert A. Zackin, ScB; Milan Fiala, MD; David H. Henry, MD; Adrien J. Marcel, MD; Kenneth L. Combs, MD; Jeffrey Vieira, MD; Howard A. Liebman, MD; Lawrence A. Cone, MD; Kathryn S. Hillman, BA; and A. Arthur Gottlieb, MD
[+] Article, Author, and Disclosure Information

Grant Support: In part by contracts from Imreg, Inc.

Requests for Reprints: Marise S. Gottlieb, MD, Imreg, Inc., One Kendall Square, Building 400, Cambridge, MA 02139.

Current Author Addresses: Drs. Gottlieb and Gottlieb and Mr. Zackin and Ms. Hillman: Imreg, Inc., One Kendall Square, Building 400, Cambridge, MA 02139.

Dr. Fiala: Eisenhower Medical Center, 39000 Bob Hope Drive, Kiewit Building, Suite 402, Rancho Mirage, CA 92270.

Dr. Henry: Graduate Hospital, Pepper Pavilion, Suite 505, 19th and Lombard Streets, Philadelphia, PA 19146.

Dr. Marcel: Community Research Initiatives, 31 West 26th Street, New York, NY 10010.

Dr. Combs: 501 Frenchmen Street, New Orleans, LA 70116.

Dr. Vieira: The Brooklyn-Caledonian Hospital, 121 DeKalb Avenue, Brooklyn, NY 11201.

Dr. Liebman: Boston City Hospital, 818 Harrison Avenue, Boston, MA 02118.

Dr. Cone: Eisenhower Medical Center, Probst Professional Building, Suite 308, 39000 Bob Hope Drive, Rancho Mirage, CA 92270.

©1991 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1991;115(2):84-91. doi:10.7326/0003-4819-115-2-84
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Objective: To determine if a 6-month course of therapy with IMREG-1, a leukocyte-derived immunomodulator, slows disease progression in patients with AIDS-related complex.

Design: Randomized, double-blind trial.

Setting: Five academic- and three community-based clinics.

Patients: Immunocompromised patients (143) with HIV.

Interventions: IMREG-1 or placebo every 2 weeks (13 doses).

Main Results: Twelve of forty-eight patients on placebo and 5 of 95 patients on IMREG-1 experienced adverse events (AIDS-defining opportunistic infection or neoplasm, wasting syndrome, HIV-associated encephalopathy, or peripheral sensory neuropathy). Based on an intention-to-treat analysis, Kaplan-Meier event probabilities were 26% for the placebo group and 6% for the IMREG-1 group (P < 0.001); based on the Cox proportional hazards model, the relative risk for patients on placebo compared with patients on IMREG-1 was 5.1 (95% Cl, 1.8 to 14.8). The frequency of symptoms significantly increased from baseline in patients receiving placebo. The mean decrease in CD4+ cells from baseline was 80 X 106 cells/L in the placebo group and 29 X 106 cells/L in patients on IMREG-1, with 20% (8) and 38% (32) of patients, respectively, showing a trend toward an increase (P = 0.04). In patients receiving IMREG-1, the size and rate of delayed hypersensitivity responses were larger than in the placebo group.

Conclusions: Patients with AIDS-related complex experienced fewer adverse events and constitutional symptoms after IMREG-1 treatment. The slower loss of CD4+ cells and increased size and rate of delayed hypersensitivity responses most likely reflect the effect of IMREG-1 on the immune system. No toxicity related to IMREG-1 administration was observed.





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