AEGiS-11IAC: Absence of clinical, immunological and virological progression after 36 months in HIV-1 infected patients immunized against alpha interferon.

11th International AIDS Conference

Vancouver, British Columbia — July 7-12, 1996

Absence of clinical, immunological and virological progression after 36 months in HIV-1 infected patients immunized against alpha interferon.

Int Conf AIDS 1996 Jul 7-12; 11:220 (abstract no. Th.B.174)
Gringeri A, Santagostino E, Cusini M, Muca-Perja M, Gucciardo G, Mannucci PM, Hermans P, Burny A, Chams V, Zagury JF, Bizzini B, Zagury D; A. Bianchi Bonomi Hemophilia & Thrombosis Center, Institute of Internal Medicine, IRCCS Maggiore Hospital and University of Milan, Italy. Fax: +39-2-54.57.074.

Subjects: Forty HIV-1-infected patients, at early stage of disease (asymptomatic with CD4 cell counts 300-600) and without concomitant or pregressed antiretroviral therapy and 11 at more advanced stage of disease (asymptomatic but with CD4 cell counts 100-400/mm3) already on antiretroviral therapy, have been followed.up since November 1992 when they were enrolled in phase I/II studies, to evaluate safety and immunogenicity on an anti-interferon alpha (IFNalpha) vaccine. This strategy is aimed at modulating the impaired cytokine network in HIV disease by counteracting IFNalpha overproduction. Outcomes after 24-36 months (median 30) were compared to those of 62 patients fulfilling the same enrollment criteria and comparable for gender, risk factor and age, regularly followed-up at our Center. Immunization: Anti-IFNalpha immunization consisted in 4-6 intramuscular injections at 1 month apart of a water-in-oil of 500 micrograms formalin-inactivated recombinant IFNalpha-2b (iIFNalpha), followed every 3 months by intramuscular injection of 250 micrograms iIFNalpha adsorbed onto calcium phosphate.

RESULTS: Complete clinical non-progression of the disease was observed in IFNalpha-immunized patients over the followup period together with a stabilization of immunological parameters, such as CD4 cell counts, and serum viral particle counts (multitarget RNA/DNA PCR). On the contrary, clinical and immunological progression was observed among open comparison patients. Furthermore, non-progression of IFNalpha-immunized patients was associated with decreased serum IFN levels, whereas open comparison patients showed increasing IFN levels.

CONCLUSIONS: these data suggest the hypothesis that anti-IFNalpha immunization might be helpful in the treatment of HIV-1-infected patients, but only a randomized, placebo-controlled, phase II/III trial will confirm these findings.

Keywords: AEGIS, HIV-1, CD4 Lymphocyte Count, HIV Infections, Interferon-alpha, Human, virology, immunology, diagnosis, ICA11

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ThB174