The aim of the present study, a multicentre trial of didanosine (ddI) compassionate use, was to identify factors associated with a better outcome in patients given ddI monotherapy. Enrolled were 1047 HIV-positive patients intolerant of and/or unresponsive to zidovudine (ZDV) therapy, with CD4+ cell counts of < 200/mu l or AIDS. Didanosine was given at a dose of 250 mg b.i.d. (patients greater than or equal to 60 kg) or 167 mg b.i.d. (patients < 60 kg), Clinical examinations and laboratory tests were performed every two months, Endpoints included death, the occurrence of a new AIDS-defining disease, or permanent discontinuation of ddI for a severe adverse event, At entry, the median CD41 cell count was 47/mu l and the median duration of prior ZDV treatment 19 months; 446 patients (43%) were classified as having AIDS, Severe toxicity occurred in 143 subjects (14%); the frequency of pancreatitis was very low (0.2%), The benefit in terms of CD4+ cell counts was greater for patients whose counts exceeded 100/mu l at entry and remained at this level until month 12 in those patients still receiving treatment, Death and/or new AIDS-defining events were observed in 374 cases (36%) over a median follow-up of eight months, AIDS dementia was observed in 11 patients (1%), Multivariate analysis of survival without disease progression showed that the factors associated with a worse outcome include the severity of immunodepression, a diagnosis of AIDS at entry, and a history of both intolerance of and clinical resistance to ZDV, Surprisingly, the patients who had received previous prolonged treatment with ZDV had a better outcome, In conclusion, severely immunodepressed patients previously administered long-term monotherapy may receive a short-term benefit from being switched to another antiretroviral drug.

Italian multicentre study of didanosine compassionate use in advanced HIV infection / A. D'Arminio Monforte, M. Musicco, M. Galli, C. Paga, A. LaRegina, A. Lazzarin, G. Angarano, F. Milazzo, F. Gritti, M. Arlotti, F. Mazzotta, G. Visco, F. Aiuti, M. Moroni, F. Alberici, M. Anselmo, M. Azzini, A. Balestreri, T. Bini, S. Rusconi, G. Cadeo, P. Cadrobbi, A. Cajozzo, R. Caputo, A. Cargnel, G. Carnevale, G. Carosi, G. Caruso, G. Cascio, F. Chiodo, A. Colomba, E. Concia, L. Contu, R. DeBiasi, F. DeCataldo, F. DeLalla, B. DeRienzo, M. Dini, P. Fassio, T. Ferraro, F. Fiaccadori, R. Frongillo, M. Gargiulo, F. Ghinelli, P. Grima, F. Giannelli, V. Giannini, P. Gioannini, W. Grillone, F. Leoncini, M. Mazzucconi, L. Massimo, M. Montroni, P. Mannucci, I. Marinucci, A. Nunnari, R. Niutta, A. Orani, L. Ortona, G. Pagano, G. Papa, G. Panichi, S. Pauluzzi, E. Petrelli, M. Pedrazzoli, N. Piersantelli, R. Pristera, S. Ranieri, P. Ricciardiello, E. Rinaldi, A. Rizzo, S. Romagnani, G. Scalise, F. Sorice, F. Suter, A. Scasso, M. Soranzo, A. Staiti, U. Tirelli, M. Toti, C. Traina, V. Veglio. - In: EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES. - ISSN 0934-9723. - 16:2(1997 Feb), pp. 135-142.

Italian multicentre study of didanosine compassionate use in advanced HIV infection

A. D'Arminio Monforte;M. Galli;M. Moroni;S. Rusconi;
1997-02

Abstract

The aim of the present study, a multicentre trial of didanosine (ddI) compassionate use, was to identify factors associated with a better outcome in patients given ddI monotherapy. Enrolled were 1047 HIV-positive patients intolerant of and/or unresponsive to zidovudine (ZDV) therapy, with CD4+ cell counts of < 200/mu l or AIDS. Didanosine was given at a dose of 250 mg b.i.d. (patients greater than or equal to 60 kg) or 167 mg b.i.d. (patients < 60 kg), Clinical examinations and laboratory tests were performed every two months, Endpoints included death, the occurrence of a new AIDS-defining disease, or permanent discontinuation of ddI for a severe adverse event, At entry, the median CD41 cell count was 47/mu l and the median duration of prior ZDV treatment 19 months; 446 patients (43%) were classified as having AIDS, Severe toxicity occurred in 143 subjects (14%); the frequency of pancreatitis was very low (0.2%), The benefit in terms of CD4+ cell counts was greater for patients whose counts exceeded 100/mu l at entry and remained at this level until month 12 in those patients still receiving treatment, Death and/or new AIDS-defining events were observed in 374 cases (36%) over a median follow-up of eight months, AIDS dementia was observed in 11 patients (1%), Multivariate analysis of survival without disease progression showed that the factors associated with a worse outcome include the severity of immunodepression, a diagnosis of AIDS at entry, and a history of both intolerance of and clinical resistance to ZDV, Surprisingly, the patients who had received previous prolonged treatment with ZDV had a better outcome, In conclusion, severely immunodepressed patients previously administered long-term monotherapy may receive a short-term benefit from being switched to another antiretroviral drug.
immunodeficiency-virus infection; controlled trial; double-blind; continued zidovudine; therapy; deteriorate; resistance; intolerant; disease; AZT
Settore MED/17 - Malattie Infettive
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/207470
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