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Quinto Programma Nazionale Di Ricerca Sull'aids PROGRESS

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Quinto Programma Nazionale Di Ricerca Sull'aids PROGRESS ISTITUTO SUPERIORE DI SANITÀ Quinto programma nazionale di ricerca sull’AIDS Istituto Superiore di Sanità Roma, 2-6 maggio 2005 PROGRESS REPORT A cura del Centro di Coordinamento, organizzazione e verifica dei progetti per la lotta all’AIDS ISSN 0393-5620 ISTISAN Congressi 05/C1 Istituto Superiore di Sanità Quinto Programma nazionale di ricerca sull’AIDS. Istituto Superiore di Sanità. Roma, 2-6 maggio 2005. Progress report. A cura del Centro di coordinamento organizzazione e verifica dei progetti per la lotta all’AIDS 2005, 332 p. ISTISAN Congressi 05/C1 (in italiano e inglese) Il quinto Programma nazionale di ricerca sull’AIDS è suddiviso nei seguenti progetti: A1) Epidemiologia dell’HIV/AIDS; A2) Eziopatogenesi e studi immunologici e virologici dell’HIV/AIDS; A3a) Ricerca, clinica e terapia delle malattie da HIV; A3b) Coinfezioni, infezioni opportunistiche e tumori associati all’AIDS; B) Azione concertata italiana per lo sviluppo di un vaccino contro HIV/AIDS (ICAV); C) Aspetti psicosociali. Parole chiave: AIDS, Programma nazionale di ricerca, Ricerca sanitaria, Sanità pubblica Istituto Superiore di Sanità Fifth National Research Program on AIDS. Istituto Superiore di Sanità. Rome, 2-6 May 2005. Progress report. Edited by the Centro di coordinamento, organizzazione e verifica dei progetti per la lotta all’AIDS 2005, 332 p. ISTISAN Congressi 05/C1 (in Italian and English) The fifth National Research Program on AIDS is subdivided into the following projects: A1) HIV/AIDS Epidemiology; A2) HIV/AIDS Etiopathogenesis and immunological and virological studies; A3A) Clinical research and therapy of HIV disease; A3B) Coinfections, opportunistic infections and AIDS related tumors; B) Italian concerted action on the development of a vaccine against HIV/AIDS – ICAV; C) Psychological and social aspects of HIV/AIDS. Key words: AIDS, National research project, Health research, Public health Questo rapporto è a cura del Centro di coordinamento organizzazione e verifica dei progetti per la lotta all’AIDS: Giovanni Caricati (Responsabile) Veronica Bizzotti Francesca Celletti Mario Falchi Flavia Fedeli Valerio Occhiodoro Si ringraziano della collaborazione per gli aspetti informatici Fabio Maccari, Mariano Santaquilani e Marco Tallon del Settore Informatico dell’Istituto Superiore di Sanità. Per informazioni su questo documento scrivere a: [email protected] Il rapporto è disponibile online sul sito di questo Istituto: www.iss.it. Presidente dell’Istituto Superiore di Sanità e Direttore responsabile: Enrico Garaci Registro della Stampa - Tribunale di Roma n. 131/88 del 1° marzo 1988 Redazione: Paola De Castro, Sara Modigliani e Sandra Salinetti La responsabilità dei dati scientifici e tecnici è dei singoli autori. © 2005 Istituto Superiore di Sanità (Viale Regina Elena, 299 - 00161 Roma) INDICE Progetto Epidemiologia dell’HIV/AIDS Responsabili scientifici Dr. Leonardo PALOMBI e Dr. Giovanni REZZA....................................................................... 1 Progetto Eziopatogenesi e studi immunologici e virologici dell’HIV/AIDS Responsabili scientifici Prof. Fernando AIUTI e Dr.ssa Barbara ENSOLI ....................................................................... 27 Progetto Ricerca clinica e terapia delle malattie da HIV Responsabili scientifici Prof. Mauro MORONI e Dr. Stefano VELLA............................................................................. 127 Progetto Coinfezioni, infezioni opportunistiche e tumori associati all’AIDS Responsabili scientifici Prof. Antonio CASSONE e Prof. Luigi ORTONA...................................................................... 191 Progetto Azione concertata italiana per lo sviluppo di un vaccino contro HIV/AIDS Responsabili scientifici Dr.ssa Barbara ENSOLI e Prof.ssa Paola VERANI .................................................................... 237 Progetto Aspetti psicosociali Responsabili scientifici Prof. Antonio BOSCHINI e Dr. Giovanni REZZA ..................................................................... 299 Indice degli autori ................................................................................................................... 319 i ii Progetto Epidemiologia dell’HIV/AIDS Responsabili scientifici Prof. Leonardo PALOMBI e Dr. Giovanni REZZA 1 2 RISPOSTA ALLA TERAPIA ANTIRETROVIRALE IN UNA COORTE DI PAZIENTI HIV-POSITIVI CON MALATTIA NEUROLOGICA Maria Letizia Giancola* (IRCCS L. Spallanzani, Roma); Maria Paola Trotta (*); Patrizia Lorenzini (*); Antonella Cingolani** (Università Cattolica Sacro Cuore, Roma); Simona Bossolasco*** (IRCCS S. Raffaele, Milano); Dora Larussa (*); Susanna Grisetti (*); Marco Bongiovanni° (Ospedale L. Sacco, Milano); Francesca Moretti (Università degli Studi di Brescia); Maria Grazia Finazzi (Ospedali Riuniti di Bergamo); Adriana Ammassari (**); Antonella D’Arminio Monforte (°); Paola Cinque (***); Andrea Antinori (*) Background: Le patologie neurologiche rimangono tra le principali manifestazioni cliniche della malattia da HIV, tuttavia l’impatto delle patologie del SNC sull’efficacia clinica e viro-immunologica della terapia antiretrovirale non è stato ancora valutato dettagliatamente. Metodi: IRINA (Italian Registry Investigation Neuro-AIDS) è uno studio multicentrico nazionale clinico-epidemiologico, sui nuovi casi di patologia neurologica HIV-relati. Da gennaio 2000, dai 45 centri partecipanti, sono stati segnalati oltre 1200 casi. Per la presente analisi sono stati selezionati tutti i pazienti (pz) con almeno 30 giorni di HAART dopo la diagnosi neurologica. Principali end- points: 1) risposta virologica (RV: valori di HIV-RNA <50 cp/ml dopo 12 mesi di terapia antiretrovirale); 2) risposta immunologica (RI: aumento di almeno 100 cell/mmc dal baseline); 3) progressione clinica (PC: decesso o nuovo evento AIDS). Risultati: 571 pz inclusi: alla diagnosi il 31.5% aveva un precedente evento AIDS; i valori mediani di CD4 e HIV-RNA plasmatico erano 68 cell/mmc (IQR 22-167) e 4.95 log10 cp/ml (IQR 3.90-5.48); 280 (49%) pz erano naive, mentre 291 (51%) erano stati trattati per un tempo mediano di 64 (IQR 44- 87) mesi. Per l’analisi è stato seguito un criterio intention to treat. Il 42% dei pz mostrava una RV (55% nei naive e 29% negli experienced). In analisi multivariata, i predittori di RV erano: una maggiore durata del primo schema di terapia dopo la diagnosi neurologica (AOR 1.06; 95% CI 1.00- 1.13 per ogni mese di terapia) e i valori più bassi di viremia plasmatica dopo 6 mesi di terapia (AOR: 0.46; 0.35-0.60 per ogni log10 in più). La RI veniva riscontrata nel 38% (50% nei naive e 25% negli experienced); un incremento di linfociti CD4 dopo 6 mesi di terapia si associava ad una probabilità aumentata di RI (AOR: 1.65 per ogni incremento di 50 cell/mmc; 95%CI 1.40-1.95). Dopo una mediana di 10 mesi (IQR 2-20) di osservazione, si osservavano 269 decessi e 76 nuovi eventi AIDS, con una probabilità stimata del 61% ad 1 anno dalla diagnosi. Al modello multivariato di Cox, la diagnosi di PML (AHR: 2.51; 95%CI 1.00-6.03), di PCNSL o localizzazioni al SNC di linfomi non- Hodgkin (AHR: 5.07; 95%CI 1.44-17.79) e la tossicodipendenza (AHR 2.09; 95%CI 1.16-3.74) si associavano ad un aumentato rischio di PC. Fattori predittivi di risposta clinica erano: l’aver iniziato terapia HAART dopo la diagnosi neurologica (AHR: 0.23; 95%CI 0.09-0.57), e l’iniziale risposta virologica (AHR: 0.77 per ogni log10 di riduzione di HIV-RNA; 95%CI 0.65-0.92) ed immunologica (AHR: 0.76 per ogni incremento di 50 cell/mmc; 95%CI 0.65-0.89) dopo 6 mesi. Nel sottogruppo di pz naïve, l’unico predittore di RV era la RV precoce, mentre i predittori di RI erano la RI precoce ed una maggiore durata del primo schema di terapia dopo la diagnosi. Dopo una mediana di 18 mesi di osservazione: 42 decessi e 28 nuovi eventi AIDS (probabilità a 1 anno: 21%). La RI a 6 mesi era l’unico fattore associato alla PC. Conclusioni: La presenza di malattia neurologica non sembra inficiare l’efficacia viro-immunologica della terapia, mentre è determinante per l’outcome clinico. La risposta precoce è essenziale per il raggiungimento di un successo sostenuto nel tempo. Contributo: 20F.1 3 UTILIZZO DEL TEST DELLA DETERMINAZIONE DELL’INDICE DI AVIDITÀ DEGLI ANTICORPI ANTI-HIV PER IDENTIFICARE LE INFEZIONI RECENTI IN CAMPIONI DI INDIVIDUI EUROPEI ED AFRICANI INFETTATI DA CEPPI DI HIV-1 APPARTENENTI A DIFFERENTI SOTTOTIPI Daniela Bernasconi* (Istituto Superiore di Sanità, Roma); Lara Tavoschi (*); Michele Chiappi (*); Eftyhia Vardas (CHBH, Johannesburg); Claudia Rovetto (*); Barbara Suligoi (*); Barbara Ensoli (*); Stefano Buttò (*) Background: La determinazione del tasso di incidenza di infezione da HIV, in particolare nei paesi in via di sviluppo, più colpiti dalla diffusione del virus, è chiave per acquisire conoscenze sulle caratteristiche della trasmissione dell’HIV nella popolazione e mettere in atto strategie atte a contenerne la diffusione. I tassi di incidenza di infezione si calcolano attraverso studi longitudinali mirati a determinare nuove sieroconversioni. Ciò è però costoso e difficile da organizzare. Recentemente è stato proposto l’utilizzo di test commerciali per la determinazione degli anticorpi contro l’HIV, che, opportunamente modificati, possono permettere di identificare le sieroconversioni recenti e, pertanto, essere utilizzati per stimare l’incidenza di infezione in una determinata popolazione. Queste procedure si basano sulla determinazione dell’avidità dell’anticorpo verso gli antigeni HIV, la quale aumenta nel tempo dalla sieroconversione. Tale procedura, essendo
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