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2. A Randomized Trial Comparing the Introduction of Ritonavir or Indinavir in 1251 Nucleoside-Experienced Patients with Advanced HIV Infection

Author

Floridia, M., Tomino, C., Bucciardini, R., Ricciardulli, D., Fragola, V., Pirillo, M. F., Amici, R., Giannini, G., Galluzzo, C. M., Andreotti, M., Seeber, A. C., Ammassari, A., Cingolani, A., Lazzarin, A., Scalise, G., Cargnel, A., Suter, F., Milazzo, F., Pastore, G., Moroni, M., Ciammarughi, R., Pini, R., Carosi, G., D'Amato, C., Contu, L., Concia, E., Bonazzi, L., Aiuti, Fernando, Vigevani, G., Vella, S., Iss Ip1 Clinical Investigators, and Mezzaroma, Ivano

Subjects
Adult, Male, medicine.medical_specialty, Anti-HIV Agents, Immunology, HIV Infections, Indinavir, Biology, law.invention, Randomized controlled trial, law, Virology, Internal medicine, medicine, Humans, Adverse effect, Aged, Ritonavir, Nucleoside analogue, Middle Aged, CD4 Lymphocyte Count, Discontinuation, Treatment Outcome, Infectious Diseases, Concomitant, Relative risk, HIV-1, RNA, Viral, Reverse Transcriptase Inhibitors, Drug Therapy, Combination, Female, medicine.drug
Abstract

ISS-IP1, a multicenter, randomized, 48-week open trial, was designed to compare the introduction of ritonavir or indinavir in patients with previous nucleoside experience and CD4+ cell counts below 50/mm3. Concomitant antiretroviral treatment with nucleoside analogs was allowed. Primary efficacy measures were survival and time to a new AIDS-defining event or death, analyzed through the whole period of observation by the intention-to-treat approach. Primary toxicity measures were time to treatment discontinuation and adverse events, grade at least 3/serious, analyzed by an on-treatment approach. Evaluation-of efficacy also included CD4+ cell and RNA response. The trial enrolled 1251 patients in 5 months. At baseline, mean CD4+ cell count was about 20 cells/mm3 and mean HIV RNA copy number was 4.9 log10/ml in both groups. Overall, 402 patients in the ritonavir group and 250 patients in the indinavir group permanently discontinued the assigned treatment (relative risk, 1.96; 95% CI, 1.68-2.30; p = 0.0001), with most of this difference dependent on a higher number of discontinuation for adverse events in the ritonavir group. After a mean follow-up of 307 days (ritonavir, 304; indinavir, 309), 124 deaths (ritonavir, 61; indinavir, 63; relative risk, 0.96; 95% CI, 0.67-1.36; p = 0.80) and 330 new AIDS-defining events (ritonavir, 170; indinavir, 160; relative risk, 1.05; 95% CI, 0.85-1.31; p = 0.60) were observed. CD4+ cell counts increased in both groups in patients still receiving treatment, with about 100 cells gained by week 24 and 150 cells gained by week 48. Body weight also increased over time in both groups. Analysis of RNA response showed a decrease of 1.5 log10 or higher in both treatment groups. Overall, 400 patients in the ritonavir group and 338 patients in the indinavir group developed at least one grade 3/serious new adverse event during follow-up (relative risk, 1.48; 95% CI, 1.28-1.72; p = 0.0001). Favorable CD4+ cell and RNA responses at 24 and 48 weeks were observed in both groups of patients remaining on treatment. Indinavir showed slightly better effects in sustaining RNA, CD4+ cell, and body weight responses. Ritonavir and indinavir results were comparable in terms of clinical outcome (survival and AIDS-defining events).

Published
2000
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3. Virologic and immunologic response to regimens containing nevirapine or efavirenz in combination with 2 nucleoside analogues in the Italian Cohort Naive Antiretrovirals (I.Co.N.A.) study

Author

Cozzi-Lepri, Alessandro, Phillips, Andrew N., D'Arminio Monforte, Antonella, Piersantelli, Nicoloò, Orani, Anna, Petrosillo, Nicola, Leoncini, Francesco, Scerbo, Antonio, Tundo, Paolo, Abrescia, Nicola, Montroni, M., Scalise, G., Costantini, Alessia, Del Prete, M. S., Tirelli, U., Nasti, G., Pastore, G., Ladisa, N., Perulli, L. M., Suter, F., Arici, C., Chiodo, F., Gritti, F. M., Colangeli, V., Fiorini, C., Guerra, L., Carosi, G., Cadeo, G. P., Castelli, F., Minardi, C., Vangi, D., Rizzardini, G., Migliorino, G., Manconi, P. E., Piano, P., Ferraro, T., Scerbo, A., Pizzigallo, E., Ricci, Fiammetta, Rinaldi, E., Pusterla, L., Carnevale, G., Galloni, D., Viganò, P., Mena, M., Ghinelli, F., Sighinolfi, L., Leoncini, F., Mazzotta, F., Ambu, S., Lo Caputo, S., Angarano, G., Grisorio, B., Ferrara, S., Grima, P., Tundo, P., Pagano, G., Piersantelli, N., Alessandrini, A., Piscopo, R., Toti, M., Chigiott, S., Soscia, F., Tacconi, L., Orani, A., Castaldo, G., Scasso, A., Vincenti, A., Scalzini, A., Alessi, F., Moroni, M., Lazzarin, A., Cargnel, A., Vigevani, G. M., Caggese, L., d’Arminio Monforte, A., Bongiovanni, M., Novati, R., Delfanti, F., Merli, S., Pastecchia, C., Moioli, C., Esposito, R., Mussini, C., Abrescia, N., Chirianni, A., Izzo, OMAR CARLO ENRICO, Piazza, M., De Marco, M., Montesarchio, V., Manzillo, E., Nappa, S., Colomba, A., Abbadessa, V., Prestileo, T., Mancuso, S., Filice, G., Minoli, L., Bruno, R., Maserati, R., Pauluzzi, S., Tosti, A., Alberici, F., Sisti, M., Menichetti, F., Smorfa, A., De Stefano, C., Lagala, A., Zauli, T., Ballardini, G., Bonazzi, L., Ursitti, M. A., Ciammarughi, R., Ortolani, P., Ortona, L., Dianzani, F., Antinori, A., Antonucci, G., D’Elia, S., Ippolito, G., Narciso, P., Petrosillo, N., Rezza, G., Vullo, V., De Luca, A., Del Forno, A., Capobianchi, M. R., Zaccarelli, M., De Longis, P., Ciardi, M., Girardi, E., D’Offizi, G., Noto, P., Pezzotti, P., Bugarini, R., Lichter, M., Mura, M. S., Mannazzu, M., Caramello, P., Caramello, A., Soranzo, M. L., Gennero, L., Sciandra, M., Salassa, B., Grossi, P. A., Basilico, C., Poggio, A., Bottari, G., Raise, E., Pasquinucci, S., De Lalla, F., Tositti, G., Resta, F., and Chimienti, A.

Subjects
Cyclopropanes, Adult, Male, medicine.medical_specialty, Efavirenz, Nevirapine, Settore MED/17 - Malattie Infettive, Adolescent, Antiretroviral Therapy, Pharmacology, Efficacy, Cohort Studies, chemistry.chemical_compound, Drug Therapy, Antiretroviral Therapy, Highly Active, Internal medicine, Oxazines, medicine, Humans, Immunology and Allergy, Highly Active, Viral, Sida, Aged, Acquired Immunodeficiency Syndrome, biology, Reverse-transcriptase inhibitor, business.industry, Middle Aged, biology.organism_classification, Confidence interval, Benzoxazines, CD4 Lymphocyte Count, Infectious Diseases, chemistry, Alkynes, Cohort, Combination, RNA, Viral, RNA, Drug Therapy, Combination, Female, business, Cohort study, medicine.drug
Abstract

This nonrandomized study compared the virologic and immunologic responses to potent regimens containing either efavirenz or nevirapine after considering potential systematic differences between patients receiving these drugs. Virologic failure was defined as the first of 2 consecutive measurements of virus load >500 human immunodeficiency virus RNA copies/mL. Of the 694 patients included in the analysis, 460 (66.3%) started nevirapine and 234 (33.7%) started efavirenz. The adjusted relative hazard of virologic failure for patients who started nevirapine, compared with those who started efavirenz, was 2.08 (95% confidence interval, 1.37-3.15; P=.0006). In addition, patients receiving efavirenz tended to recover 5 CD4 cells/microL more per quarter (P=.05). Although comparisons of drug efficacy in nonrandomized studies should be viewed with caution, no results from randomized controlled comparisons of these drugs are thought to be available. The findings of this study are in agreement with those of other observational studies.

Published
2002

4. Terapia antiretrovirale in pazienti naives ed experienced in condizioni di vita reale: lo studio MASTER-1

Author

Castelli, Francesco, Suter, F, Orani, Am, Andreoni, A, Carnevale, G, Vigevani, Gm, Minoli, R, Pastore, G, Cadeo, Gp, Ciammarughi, R, Toti, M, Chirianni, A, Mazzotta, F, Ghinelli, F, Pauluzzi, S, Ranieri, S, Colomba, A, Riccio, G, Gritti, F, Poggio, A, Rizzo, F, Fiori, Gp, DE LALLA, F, Scalzini, A, Leoncini, G, Moroni, M, Cadrobbi, P, Borri, A, Milazzo, F, Maggiolo, F, Castaldo, G, Lingua, A, Pan, A, Visona', R, Maserati, R, Ladisa, N, Paraninfo, G, Tinelli, C, Chiodera, A, Torti, Carlo, Faisti, C, Palvarini, L, Patroni, A, and Carosi, Giampiero

Published
1999

5. The MASTER Study: aggressive versus conservative therapy in naive HIV patients

Author

Castelli, Francesco, Fausti, C, Chiodera, A., Suter, F, Maggiolo, F, Orani, A. M., Andreoni, A, Pan, A, Vigevani, Gm, Minoli, L, Maserati, R, Tinelli, C, Pastore, G, Cadeo, Gp, Ciammarughi, R, Toti, M, Chirianni, A, Mazzotta, F, Ghinelli, F, Pauluzzi, S, Ranieri, S, Colomba, A, Riccio, G, Gritti, F, and AND THE MASTER STUDY GROUP, CAROSI G.

Published
1998

6. Lo studio di coorte I.CO.N.A. (Italian CohOrt Naive Antiretrovirals): caratteristiche all’arruolamento dei primi 1676 soggetti

Author

DARMINIO MONFORTE, A, Arici, C, Ippolito, G., Rezza, G., Angarano, G., Carosi, G., Vhiodo, F., Dianzani, F., Di Luzio Paparatti, U., Lazzarin, A., Ortona, L., Garattini, L., Musicco, M., Pezzotti, P., Vella, S., Abrescia, N., Aceti, A., Alberici, F., Armignacco, O., Bonazzi, L., Cadeo, G. P., Cadrobbi, P., Caggese, L., Cargnel, A., Carnevale, G., Chirianni, A., Ciammarughi, R., Colomba, A., D'Amato, C., De Lalla, F., D'Elia, S., Dealla Santa, M., De Rienzo, B., De Stefano, C., Ferraro, T., Filice, G., Fiori, G. P., Gavazzeni, G., Ghinelli, F., Gioannini, P., Grilone, W., Grima, P., Grisorio, B., Gritti, F. M., Leoncini, F., Manconi, P. E., Mazzotta, F., Milazzo, F., Minoli, L., Montroni, M., Narciso, P., Orani, A., Pauluzzi, S., Piazza, M., Piersantelli, N., Pizzigallo, E., Poggio, A., Reaise, E., Ranieri, S., Resta, F., Rizzo, F., Rosci, M. A., Scalise, G., Scalzini, A., Scasso, A., Soranzo, M. L., Soscia, F., Suter, F., Tirelli, U., Toti, M., Viganò, P., Vigevani, G. M., Vullo, V., Ravasio, L., Girardi, E., Federico, M. D., Castelli, Francesco, Colangeli, V., Capobianchi, M., Sinnone, M. S., Antinori, A., Boccia, L., Mannazzu, M., Sisti, M., DE LOngis, P., Ursitti, M. A., Vangi, D., Scaggiante, R., Moioli, M. C., Adriani, B., Pan, A., Montesarchio, M., Arlotti, M., Prestileo, T., Palmieri, F., Franzetti, M., Ciardi, M., Smorfa, A., Mussini, C., Armignacco, L., Cosco, L., Patruno Savino, F. A., Torre, D., Sighinolfi, L., Sciandra, M., Giacobbi, D., Tundo, P., Ferrara, S., Guerra, L., Ambu, S., Piano, P., Lo Caputo, S., Rizzardini, G., Maserati, R., Costantini, A., D'Offizi, G. P., Castaldo, G., Tosti, A., Nappa, S., Piscopo, R., Ricci, F., Bottari, V., Pasquinucci, S., Ballardini, G., Chimienti, A., Alessandrini, A., Zaccarelli, M., Del Prete, M. S., Costa, P., Vincenti, A., Salassa, B., Tacconi, L., Bottura, P., Nasti, G., Incandela, L., Ghiselli, G. C., Pusterla, L., Lichtner, M., and Moroni, M.

Published
1997

8. Cefotaxime in the cerebrospinal fluid and serum in patients with purulent meningitis.

Author

Peretti, P., Sueri, L., Tosi, M., Ciammarughi, R., Cadeo, G. P., and Milanesi, B.

Abstract

Cefotaxime concentrations in the cerebrospinal fluid and serum were determined in patients with purulent meningitis by means of a simple, rapid and reproducible method in agar medium.The CSF concentrations of cefotaxime fluctuated around 4 mg/l. The pharmacokinetics of the antibiotic in relation to the integrity of the blood-brain barrier was studied by means of an assay of the albumin and IgG present in the cerebrospinal fluid and in the serum. [ABSTRACT FROM PUBLISHER]

Published
1984

9. Impact of Mutations Conferring Reduced Susceptibility to Lamivudine on the Response to Antiretroviral Therapy

Author

Perno, Carlo Federico, Cozzi-Lepri, Alessandro, Balotta, Claudia, Forbici, Federica, Violin, Michela, Bertoli, Ada, Facchi, Guido, Pezzotti, Patrizio, Angarano, Gioacchino, Arici, Claudio, Narciso, Pasquale, Orani, Anna, Raise, Enzo, Scalzini, Alfredo, Poggio, Antonio, Ippolito, Giuseppe, Moroni, Mauro, Monforte, Antonella d'Arminio, Montroni, M, Scalise, G, Costantini, A, Del Prete, MS, Tirelli, U, Nasti, G, Pastore, G, Perulli, LM, Suter, F, Arici, C, Chiodo, F, Gritti, FM, Colangeli, V, Fiorini, C, Guerra, L, Carosi, G, Cadeo, GP, Castelli, F, Minardi, C, Vangi, D, Rizzardini, G, Migliorino, G, Manconi, PE, Piano, P, Ferraro, T, Cosco, L, Pizzigallo, E, Ricci, F, Vigevani, GM, Pusterla, L, Carnevale, G, Pan, A, Viganò, P, Mena, M, Ghinelli, F, Sighinolfi, L, Leoncini, F, Mazzotta, F, Ambu, S, Lo Caputo, S, Angarano, G, Grisorio, B, Ferrara, S, Grima, P, Tundo, P, Pagano, G, Piersantelli, N, Alessandrini, A., Piscopo, R., Toti, M, Chigiotti, Soscia, F, Tacconi, L, Orani, A, Castaldo, G, Scasso, A, Vincenti, A, Scalzini, A, Alessi, F, Moroni, M, Lazzarin, A, Cargnel, A, Milazzo, F, Caggese, L, Monforte, A d'Arminio, Melzi, S, Delfanti, F, Carini, B, Adriani, B, Garavaglia, S, Moioli, C, Esposito, R, Mussini, C, Abrescia, N, Chirianni, A, Perrella, O, Piazza, M, De Marco, M, Montesarchio, V, Manzillo, E, Nappa, S, Cadrobbi, P, Scaggiante, R, Colomba, A, Abbadesse, V, Prestileo, T, Mancuso, S, Filice, G, Minoli, L, Savino, FA Patruno, Maserati, R, Pauluzzi, S, Baldelli, F, Petrelli, E, Ciotti, A, Alberici, F, Sisti, M, Menichetti, F, Smorfa, A, De Stefano, C, La Gala, A, Zauli, T, Ballardini, G, Bonazzi, L, Ursitti, MA, Ciammarughi, R, Giordani, S, Ortona, L, Dianzani, F, Ippolito, G, Antinori, A, Antonucci, G, D'Elia, S, Narciso, P, Petrosillo, N, Vullo, V, De Luca, A, Del Forno, A, Zaccarelli, M, De Longis, P, Ciardi, M, D'Offizi, G, Palmieri, F, Lichter, M, Capobianchi, MR, Girardi, E, Pezzotti, P, Rezza, G, Mura, MS, Mannazzu, M, Caramello, P, Sinicco, A, Soranzo, ML, Quaglia, S, Sciandra, M, Salassa, B, Torre, D, Basilico, C, Poggio, A, Bottari, G, Raise, E, Pasquinucci, S, De Lalla, F, Tositti, G, Resta, F, Chimienti, A, Lepri, A Cozzi, and Phillips, AN

Published
2001
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12. A Sporadic Case of Diarrhoea due to Enterotoxigenic Clostridium perfringens

Author

Luzzi, I., Caprioli, A., Bisicchia, R., Ciammarughi, R., and Mastrantonio, P.

Abstract

Enterotoxigenic strains of Clostridium perfringens have been recently implicated in some cases of antibiotic associated diarrhoea, especially in hospitalised elderly patients. We present a case of diarrhoea associated with enterotoxigenic C. perfringens in a young adult not implicated in an episode of food poisoning and who did not receive antimicrobial therapy.

Published
1988
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13. [Bullous pneumopathy and spontaneous pneumothorax. Atypical radiologic patterns of Pneumocystis carinii pneumonia].

Author

Lazzari Agli L, Viglietta G, Arlotti M, Ciammarughi R, Forlani S, and Muratore F

Subjects
Acquired Immunodeficiency Syndrome complications, Adult, Diagnosis, Differential, Humans, Pneumonia complications, Pneumonia, Pneumocystis complications, Pneumothorax complications, Radiography, Retrospective Studies, Pneumonia diagnostic imaging, Pneumonia, Pneumocystis diagnostic imaging, Pneumothorax diagnostic imaging
Abstract

Pneumocystis carinii pneumonia (PCP) is certainly the most frequent opportunistic pulmonary infection in AIDS patients. Besides the conventional radiographic features demonstrating bilateral infiltrates and airspace consolidation, atypical radiologic patterns are reported in the literature, which are characterized by spontaneous pneumothorax and by the presence of bullae, cysts and areas of pulmonary cavitation. Forty consecutive PCP patients were investigated, ten of them presenting with atypical radiographic findings: 1 case of spontaneous pneumothorax with no evidence of bullae and 9 cases of bullous lung disease--5 of them complicated by spontaneous pneumothorax. Several pathogenetic hypotheses were considered; lesions evolution and the differential radiologic diagnosis were discussed. As for diagnosis, the value of chest CT scans is emphasized, together with that of HRCT which is extremely valuable to localize, characterize and evaluate bullous lesions and associated parenchymal signs.

Published
1993

15. [Cefuroxim in purulent meningitis]].

Author

Calonghi GF, Fassio PG, Sueri L, Ciammarughi R, Cadeo GP, and Gavazzeni G

Subjects
Adolescent, Adult, Child, Humans, Infant, Newborn, Middle Aged, Cefuroxime therapeutic use, Cephalosporins therapeutic use, Meningitis drug therapy
Published
1979

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