Survival and quality of life in HIV-positive patients treated with a polyantigenic immunomodulator.

A polyantigenic immunomodulator (PAI), previously known as polyantigenic vaccine, which consists of a mixture of antigens of inactivated bacteria with antigens of influenza virus in a peanut-oil-arlacel-A-aluminium monoesterate emulsion, increased tumor resistance and induced tumor regression in tumor bearing mice. This report presents clinical and laboratory data that demonstrate the effect of PAI in long term prolongation of disease free state in HIV positive patients. A total of 40 patients, 35 males and 5 females, with a mean age of 41.1 +/- 10.5 years, ranging from 28 to 68 years, HIV positive by (ELISA and Western Blot), with no restriction on the CD4 + T lymphocytes counts, were included in this open study. The PAI regimen was one subcutaneous injection per week for patients with < 400 CD4 + lymphocytes and one monthly injection for patients with CD4 + count > 400. All patients were monitored at different intervals for lymphocyte counts, clinical condition and treatment toxicity. After a follow up of eight years 81% of the patients were alive and 47% were free of disease. In patients without AIDS, the weight was 153.9 +/- 28 pounds pre-PAI and 164.6 +/- 27 (P = 1.2 x 10(-4); the CD4 + lymphocyte count was 795 +/- 421 pre-PAI and 585 +/- 279 post PAI (P = 0.08). In patients alive with AIDS, the weight was 159.5 +/- 32 pre-PAI and 163.9 +/- 32 pounds post-PAI (P = 0.8); the CD4 + lymphocyte counts was 491 +/- 255 pre-PAI and 298 +/- 142 post-PAI (P = 0.08); and five AIDS-related infections occurred in five patients. In patients who died the weight was 157.7 +/- 23 pre and 146.8 +/- 30 post (P = 0.10); and the CD4 count was 340.7 +/- 149 pre and 103.4 +/- 88 post (P = 0.0057). All died with infection. No toxicity with the use of PAI was reported. PAI improves disease free survival and quality of life in HIV + patients.

Survival and quality of life in HIV-positive patients treated with a polyantigenic immunomodulator

A polyantigenic immunomodulator (PAI), previously known as polyantigenic vaccine, which consists of a mixture of antigens of inactivated bacteria with antigens of influenza virus in a peanut-oil-arlacel-A-aluminium monoesterate emulsion, increased tumor resistance and induced tumor regression in tumor bearing mice. This report presents clinical and laboratory data that demonstrate the effect of PAI in long term prolongation of disease free state in HIV positive patients. A total of 40 patients, 35 males and 5 females, with a mean age of 41.1 +/- 10.5 years, ranging from 28 to 68 years, HIV positive by (ELISA and Western Blot), with no restriction on the CD4 + T lymphocytes counts, were included in this open study. The PAI regimen was one subcutaneous injection per week for patients with < 400 CD4 + lymphocytes and one monthly injection for patients with CD4 + count > 400. All patients were monitored at different intervals for lymphocyte counts, clinical condition and treatment toxicity. After a follow up of eight years 81 percent of the patients were alive and 47 percent were free of disease. In patients without AIDS, the weight was 153.9 +/- 28 pounds pre-PAI and 164.6 +/- 27 (P = 1.2 x 10(-4); the CD4 + lymphocyte count was 795 +/- 421 pre-PAI and 585 +/- 279 post PAI (P = 0.08). In patients alive with AIDS, the weight was 159.5 +/- 32 pre-PAI and 163.9 +/- 32 pounds post-PAI (P = 0.8); the CD4 + lymphocyte counts was 491 +/- 255 pre-PAI and 298 +/- 142 post-PAI (P = 0.08); and five AIDS-related infections occurred in five patients. In patients who died the weight was 157.7 +/- 23 pre and 146.8 +/- 30 post (P = 0.10); and the CD4 count was 340.7 +/- 149 pre and 103.4 +/- 88 post (P = 0.0057). All died with infection. No toxicity with the use of PAI was reported. PAI improves disease free survival and quality of life in HIV + patients

Characterization of the antitumor activity of a polyantigenic immunomodulator (PAI): I--Utilization of cimetidine and cyclosporine A.

Cimetidine (CMT), cyclosporine A (CsA), interleukin 2 (IL 2), were used to characterize the anticancerous effect of a polyantigenic immunodulator (PAI). PAI consists of a mixture of inactivated bacteria and influenza virus in a peanut oil-arlacel A-aluminum monoesterate emulsion. Antitumoral activity was tested on Ehrlich's ascites tumor (EAT) implanted into Swiss-Webster (allogeneic) or C57BL/6J (syngeneic) mice. PAI antitumor activity was enhanced by CMT acting synergistically by reducing substantially the tumor growth and increasing the percentage of surviving mice, while CsA suppressed this activity. PAI or its individual components were able to induce significant lymphocyte blastogenesis in mouse (C57BL/6J)-spleen lymphocytes and IL-2 enhanced considerably this lymphoproliferative response. The results suggest that PAI acts at the level of cellular immunity.

Characterization of the antitumor activity of a polyantigenic immunomodulator (PAI): II--Involvement of NK cells and adoptive immunotherapy.

Natural killer (NK) cell activity and adoptive immunotherapy were used to characterize the anticancerous effect of a polyantigenic immunomodulator (PAI). PAI consists of a mixture of inactivated bacteria and influenza virus in a peanut oil-arlacel A-aluminum monoesterate emulsion, shown previously to have antitumoral activity in mice implanted with Ehrlich's ascites tumor. The administration of PAI, its bacterial or viral component strongly increased the in vitro activity of NK cells of splenocyte populations obtained from Swiss-Webster (allogeneic) and C57BL/6J (syngeneic) mice, specially during the early post-induction period. On the other hand, PAI-sensitized, allogeneic or syngeneic lymphocytes were transferred successfully to tumor-bearing mice implanted with Ehrlich's ascites tumor, reducing tumor growth and increasing survival. The results confirm our previous suggestions that PAI acts probably at the level of cellular immunity. Therefore complex polyantigenic substances such as PAI could be used directly alone, in combination with other immunoadjuvants or to sensitize in a global manner immunocompetent cells to be employed in adoptive immunotherapy.

Inhibition of lymphocyte capping by fatty acids in mouse and man.

Lipid-enriched diets have been related to a high cancer incidence in experimental animals for many years, and more recently, to assorted defects on the immune response. We investigated the effect of incubating human or murine (C3H/HEJ) lymphocytes with saturated (16:0) and unsaturated (18:1, 18:2, 18:3, 20:4) fatty acids (12 micrograms for each 10(7) cells), on the ability to cap with antihuman or antimouse anti-IgM, mu-chain specific antibody. Capping was also tested in obese (ob/ob, C57BL/6J) mice. Capping at 30 and 60 min was reduced by fatty acid incubation to 10-30% of control values in humans (p less than .001), and to 30% of control values in mice (p less than .01), regardless of degree of unsaturation. ob/ob capped normally. A lymphocyte membrane effect caused by fatty acids is observed in these experiments. Whether this is related to the dysimmunity caused by lipid diets cannot be assessed from our data, especially since all fatty acids, regardless of unsaturation, reduced the capping phenomenon.