Response to treatment with the leukocyte-derived immunomodulator IMREG-1 in immunocompromised patients with AIDS-related complex. A multicenter, double-blind, placebo-controlled trial.
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.


METHODS
Randomized, double-blind trial.


METHODS
Five academic- and three community-based clinics.


METHODS
Immunocompromised patients (143) with HIV.


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


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 less than 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% CI, 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 10(6) cells/L in the placebo group and 29 x 10(6) 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.
Gottlieb
M S
MS
Imreg, Inc., New Orleans, Louisiana.
Zackin
R A
RA
Fiala
M
M
Henry
D H
DH
Marcel
A J
AJ
Combs
K L
KL
Vieira
J
J
Liebman
H A
HA
Cone
L A
LA
Hillman
K S
KS
D000386:AIDS-Related Complex / Q000188:drug therapy* / Q000276:immunology; D000163:Acquired Immunodeficiency Syndrome / Q000517:prevention & control; D000328:Adult; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007958:Leukocyte Count / Q000187:drug effects; D008222:Lymphokines / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011336:Probability; D016016:Proportional Hazards Models; D013223:Statistics as Topic
C049120:IMREG-1; D008222:Lymphokines