ABSENCE OF CLINICAL, VIROLOGICAL, AND IMMUNOLOGICAL SIGNS OF PROGRESSION IN HIV-1-INFECTED PATIENTS RECEIVING ACTIVE ANTI-INTERFERON-ALPHA IMMUNIZATION - A 30-MONTH FOLLOW-UP REPORT

Twenty-seven HIV-1-infected patients, 16 at early stage of disease and without concomitant antiretroviral therapy and 11 at more advanced st age of disease receiving antiretroviral therapy, have been followed si nce their enrollment, November 1992 and July 1993, respectively, in ph ase I/II studies to evaluate safety and immunogenicity of an anti-inte rferon-alpha (IFN-alpha) vaccine, aimed at modulating the impaired cyt okine network in AIDS patients by counteracting IFN-alpha overproducti on. We compared clinical, virological, and immunological markers of di sease progression, including circulating IFN-alpha levels in a 24- to 30-month follow-up period with those of 62 patients fulfilling the sam e enrollment criteria and comparable for sex, risk factor, and age, re gularly followed at our center. Anti-IFN-alpha immunization consisted of four-six intramuscular injections 1 month apart of a water-in-oil e mulsion of 500 mu g formalin-inactivated recombinant IFN-alpha-2b (iIF N-alpha) followed by intramuscular injections of 250 mu g iIFN-alpha a dsorbed onto calcium phosphate every 3 months. Neither clinical deteri oration nor a CD4(+) cell count decrease from pretreatment values was observed in IFN-alpha-immunized patients in the follow-up period, wher eas clinical and immunological disease progressions were observed amon g open-comparison patients. Furthermore, statistical analysis showed a strong association between occurrence of clinical manifestations and high circulating IFN-alpha titers, while nonprogression of IFN-alpha-i mmunized patients was associated with decreased levels of circulating IFN-alpha.