Summary
A case-control, prospective, open-label, clinical trial to evaluate efficacy and safety of a combined zidovudine/Thymus Humoral Factor Gamma-2 (THF) therapy in HIV-infected subjects was conducted in 13 patients. Twenty-six patients were included as controls receiving only zidovudine. The two groups of patients were matched according to sex, age, CDC stage of HIV infection, number of CD4+ T cells and type of previous opportunistic infections (if any) and all patients and controls were naive for antiretroviral therapy at the moment they entered the trial. The observation period was protracted up to 47 months (mean 28±13 months). No significant difference was observed between the two groups as far as surrogate markers of HIV disease progression are concerned. However, patients receiving zidovudine and THF showed a lower number of opportunistic complications. Only one patient in this group progressed to manifest AIDS while 9 of 18 controls presented disease progression. Four patients died in the case group, all of them were CDC stage IV at admission, and 15 of 26 died in the control group (all CDC stage IV at admission, and four patients who presented disease progression during the study period). Survival time was increased in the case group. The exact immunological effect of thymus hormones in HIV infection has still to be elucidated, but a possible therapeutic role of these agents is foreseeable.
References
Stein, D. S., Timpone, J. G., Gradon, J. D., Kagan, J. M., Schnittman, S. M. Immune based therapeutics: scientific rationale and the promising approaches to the treatment of the human immunodeficiency virus-infected individual. Clin. Infect. Dis. 17 (1993) 749–771.
The National Institute of Child Health and Human Development Intravenous Immunoglobulin Study Group Intravenous immune globulin for the prevention of bacterial infections in children with symptomatic human immunodeficiency virus infection. N. Engl. J. Med. 325 (1991) 73–80.
Interferon Alpha Study Group A randomised placebo-controlled trial of recombinant human interferon alpha 2a in patients with AIDS. J. Acquir. Immun. Defic. Syndr. 1 (1988) 111–118.
Real, F. X., Oettgen, H. F., Krown, S. E. Kaposi's sarcoma and the acquired immunodeficiency syndrome: treatment with high and low doses of recombinant leukocyte A interferon. J. Clin. Oncol. 4 (1986) 544–551.
Volberding, P., Valero, R., Rothman, J., Gee, G. Alpha interferon therapy of Kaposi's sarcoma in AIDS. Ann. N. Y. Acad. Sci. 437 (1986) 439–446.
Wood, R., Montoya, J. G., Kundu, S. K., Schwartz, D. H., Merigan, T. C. Safety and efficacy of polyethylene glycol-modified interleukin-2 and zidovudine in human immunodeficiency virus type 1 infection: a phase I7II study. J. Infect. Dis. 167 (1993) 519–525.
Oates, K. K., Sztein, M. B., Goldstein, A. L. Mechanism of action of the thymosins: modulation of lymphokines, receptors, and T-cell differentiation antigens. Immunol. Ser. 45 (1989) 273–288.
Baxevanis, C. N., Frillingos, S., Seferiadis, K. Enhancement of human T lymphocyte function by prothymosin alpha: increased production of interleukin-2 and expression of interleukin-2 receptors in normal human peripheral blood T lymphocytes. Immunopharmacol. Immunotoxicol. 12 (1990) 595–617.
Bustelo, X. R., Otero, A., Gomez-Marquez, J., Freire, M. Expression of the rat prothymosin alpha gene during T-lymphocyte proliferation and liver regeneration. J. Biol. Chem. 266 (1991) 1443–1447.
Safer, D., Elzinga, M., Nachmias, V. T. Thymosin β4 and Fx, an actin-sequestering peptide, are indistinguishable. J. Biol. Chem. 266 (1991) 4029–4032.
Mutchnick, M. B., Appelman, H. D., Chung, H. T. Thymosin treatment of chronic hepatitis B: a placebo-controlled pilot trial. Hepatology 14 (1991) 409–415.
Dumann, H., Meuer, S. C., Renschin, G., Koehler, H. Influence of thymopentin on antibody response and monocyte and T cell function in hemodialysis patients who fail to respond to hepatitis B vaccination. Nephron 55 (1990) 136–140.
Conant, M. A., Calabrese, L. H., Thompson, S. E., Poiesz, B. J., Rasheed, S., Hirsh, R. L., Meyerson, L. A., Kremer, A. B., Wang, C. C., Goldstein, G. Maintenance of CD4+ cells by thymopentin in asymptomatic HIV-infected subjects: results of a double-blind, placebo-controlled study. AIDS 6 (1992) 1335–1339.
Clumeck, N., Cran, S., Van de Perre, P., Mascart-Lemone, F., Duchateau, J., Bolla, K. Thymopentin treatment in AIDS and pre-AIDS patients. Surv. Immunol. Res. (Suppl. 1) (1985) 58–62.
Silvestris, F., Gernone, A., Frassanito, M. A., Dammacco, F. Immunologic effects of long-term thymopentin treatment in patients with HIV-induced lymphoadenopathy syndrome. J. Lab. Clin. Med. 113 (1989) 139–144.
Trainin, N., Handzel, Z. T., Pecht, M. Biological and clinical properties of THF. Thymus 7 (1985) 137–150.
Handzel, Z. T., Bentwich, Z., Burstein, R., Segal, O., Berner, Y., Levin, S. Antiviral properties of Thymic Humoral Factor and other thymic hormones. Clin. Immunol. Newslet. 6 (1985) 68–71.
Handzel, Z. T., Berner, Y., Segal, O. Immunoreconstitution of T-cell impairments in asymptomatic male homosexuals by Thymic Humoral Factor (THF). Int. J. Immunopharmacol. 9 (1987) 165–173.
Lazzarin, A., Barcelini, W., Uberti Foppa, C., Borghi, M. O., Franzetti, F., Cinque, P., Moroni, M. Experiences with immunomodulant agents in HIV infections. Acta. Haemat. 78 (Suppl. 1) (1987) 84–90.
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Maggiolo, F., Taras, A., Suter, F. et al. Zidovudine and thymus humoral factor gamma-2 in the treatment of HIV infection: Preliminary clinical experience. Infection 25, 35–38 (1997). https://doi.org/10.1007/BF02113505
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DOI: https://doi.org/10.1007/BF02113505