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6 results on '"Chiesa, E"'

1. Comparison of a rule-based algorithm with a phenotype-based algorithm for the interpretation of HIV genotypes in guiding salvage regimens in HIV-infected patients by a randomized clinical trial: the mutations and salvage study.

Author

Gianotti N, Mondino V, Rossi MC, Chiesa E, Mezzaroma I, Ladisa N, Guaraldi G, Torti C, Tarquini P, Castelli P, Di Carlo A, Boeri E, Keulen W, Kenna PM, and Lazzarin A

Subjects
Adult, Antiretroviral Therapy, Highly Active, Female, Genotype, HIV Protease Inhibitors therapeutic use, Humans, Italy, Male, Middle Aged, Phenotype, RNA, Viral blood, RNA, Viral genetics, Reverse Transcriptase Inhibitors therapeutic use, Viral Load, Algorithms, Anti-HIV Agents therapeutic use, HIV genetics, HIV Infections drug therapy, Mutation, Salvage Therapy
Abstract

Background: There is still considerable uncertainty as to the best algorithm for interpreting human immunodeficiency virus (HIV) genotyping results., Methods: A total of 318 subjects with HIV RNA levels of >1000 copies/mL were enrolled in 41 centers throughout Italy from 2001 through 2003, stratified on the basis of their drug history, randomized (1:1) to 2 arms to have their treatments modified on the basis of the results of HIV genotyping (as interpreted by virtual phenotype analysis or with use of a rule-based interpretation system), and followed up for 48 weeks. At least 1 nucleoside reverse-transcriptase inhibitor and 1 protease inhibitor had to be included in any new regimen; nonnucleoside reverse-transcriptase inhibitor-naive patients were also prescribed a nonnucleoside reverse-transcriptase inhibitor. Only drugs licensed in Italy were allowed. The primary end point was a decrease in HIV RNA level to <400 copies/mL by week 12 according to on-treatment analysis., Results: The mean (+/- standard deviation) values at baseline were as follows: HIV RNA level, 4.1+/-0.74 log(10) copies/mL; CD4(+) T lymphocyte count, 410+/-262 cells/microL; reverse-transcriptase mutations, 4.8+/-2.9; and protease mutations, 2.8+/-2.5. There were 133 patients (41.8%) who were nonnucleoside reverse-transcriptase inhibitor naive and protease inhibitor experienced, 63 patients (19.8%) who were nonnucleoside reverse-transcriptase inhibitor experienced and protease inhibitor naive, and 122 patients (38.4%) who were 3-class experienced. A total of 192 patients completed 12 weeks of the treatment regimen assigned at baseline; at 12 weeks, 66.3% of patients in the virtual phenotype arm and 71.3% of patients in the rule-based interpretation arm had HIV RNA levels of <400 copies/mL (P = .46). No statistically significant difference between arms was observed by intention-to-treat analysis., Conclusion: Both the virtual phenotype and rule-based interpretation methods of HIV genotyping can guide the selection of effective antiretroviral drugs for a salvage regimen.

Published
2006
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2. Comparison of a rule-based algorithm with a phenotype-based algorithm for the interpretation of HIV genotypes in guiding salvage regimens in HIV-infected patients by a randomized clinical trial: The mutations and salvage study

Author

Gianotti, N., Mondino, V., Rossi, M. C., Chiesa, E., Mezzaroma, Ivano, Ladisa, N., Guaraldi, G., Torti, C., Tarquini, P., Castelli, P., Di Carlo, A., Boeri, E., Keulen, W., Kenna, P. M., Lazzarin, A., Mutations, and Study Group Salvage Musa

Subjects
Microbiology (medical), Adult, Male, Genotype, Anti-HIV Agents, phenotype, genotype, HIV Infections, law.invention, Randomized controlled trial, Acquired immunodeficiency syndrome (AIDS), law, Antiretroviral Therapy, Highly Active, Medicine, Humans, Protease inhibitor (pharmacology), Sida, Genotyping, Salvage Therapy, Intention-to-treat analysis, algorithm, biology, business.industry, Proteolytic enzymes, HIV, HIV Protease Inhibitors, mutation, Middle Aged, Viral Load, medicine.disease, biology.organism_classification, Regimen, Infectious Diseases, Phenotype, Italy, Mutation, RNA, Viral, Reverse Transcriptase Inhibitors, Female, business, Algorithm, Algorithms
Abstract

BACKGROUND There is still considerable uncertainty as to the best algorithm for interpreting human immunodeficiency virus (HIV) genotyping results. METHODS A total of 318 subjects with HIV RNA levels of >1000 copies/mL were enrolled in 41 centers throughout Italy from 2001 through 2003, stratified on the basis of their drug history, randomized (1:1) to 2 arms to have their treatments modified on the basis of the results of HIV genotyping (as interpreted by virtual phenotype analysis or with use of a rule-based interpretation system), and followed up for 48 weeks. At least 1 nucleoside reverse-transcriptase inhibitor and 1 protease inhibitor had to be included in any new regimen; nonnucleoside reverse-transcriptase inhibitor-naive patients were also prescribed a nonnucleoside reverse-transcriptase inhibitor. Only drugs licensed in Italy were allowed. The primary end point was a decrease in HIV RNA level to

Published
2006

4. Virological success of lopinavir/ritonavir salvage regimen is affected by an lopinavir/ritonavir-related increasing number of mutations

Author

Bongiovanni, M, Bini, T, Adorni, F, Meraviglia, P, Capetti, A, Tordato, F, Cicconi, P, Chiesa, E, Cordier, L, Cargnel, A, Landonio, S, Rusconi, S, and Monforte, AD

Subjects
Virological failure, HAART, virus diseases, HIV
Abstract

We evaluated the virological outcome of lopinavir/ritonavir (LPV/RTV) in 224 HIV-1-infected and protease inhibitor (PI)-experienced patients showing virological failure to a highly active antiretroviral therapy (HAART) regimen and followed up for at least 3 months. At baseline, the median level of plasma viraemia was 4.61 log(10) copies/ml (range 3-6.48) and the median CD4 cell count was 219 cells/mm(3) (range 1-836). During a median follow-up of 272 days (range 92-635), we observed an increase in the number of CD4 cells (P=0.02) and a dramatic decrease in plasma viraemia levels (P=0.0001), which became undetectable in 122 patients (54.5%). The closely related predictive factors were baseline plasma viraemia levels and the number of mutations known to reduce susceptibility to LPV/RTV. Thirty-one patients (13.8%) discontinued LPV/RTV during the follow-up, and one AIDS event and three deaths were recorded. Of the 134 patients (59.8%) who underwent a baseline genotype resistance test, 22 (16.4%) had greater than or equal to 6 mutations known to reduce LPV/RTV susceptibility; plasma viraemia became undetectable in 76 patients (56.7%), only five of whom harboured greater than or equal to 6 mutations at baseline (P=0.0001). The independent predictive factors related to virological success were plasma viraemia levels and the number of mutations reducing susceptibility to LPV/RTV at baseline; each additional log(10) copies/ml of HIV RNA reduced the probability of virological success by 34.0% and each extra mutation by 14.5%.

Published
2003

5. Observational Study on HIV-Infected Subjects Failing HAART Receiving Tenofovir Plus Didanosine as NRTI Backbone.

Author

Bongiovanni, M., Gianotti, N., Chiesa, E., Nasta, P., Cicconi, P., Capetti, A., Biagio, A., Matti, A., Tirelli, V., Marconi, P., Luca, A., Mussini, C., Gatti, F., Zaccarelli, M., Abeli, C., Torti, C., Antinori, A., Castagna, A., and d'Arminio Monforte, A.

Subjects
HIV, SPINE, RNA, IMMUNOLOGY, NUCLEIC acids, GENOTYPE-environment interaction, CELLS, MEDIAN (Mathematics)
Abstract

We evaluated the efficacy of tenofovir (TDF) – and didanosine (ddI)-containing backbones in HIV-infected experienced subjects. We included in the study 245 subjects who started a TDF/ddI-containing HAART with HIV-RNA > 3 log10 cp/ml and an available genotypic resistance test at baseline. At baseline, median CD4 counts and HIV-RNA were 278 cell/mmc and 4.32 log10 cp/ml, respectively. Seventy-four subjects (30.2%) discontinued TDF and/or ddI, 23 of them for drug-related toxicities or intolerance. One-hundred and twenty-six (51.4%) subjects achieved virologic success (HIV-RNA < 50 copies/ml in two consecutive determinations) in a median time of 6.1 months; higher HIV-RNA levels (HR: 0.66, 95% CI: 0.54– 0.79, p < 0.001 for each additional log10 copies/ml), and the total number of mutations either for PI and NNRTI at baseline (HR: 0.87, 95% CI: 0.81–0.92, p < 0.001 for each additional mutation) were both predictors of virologic success. M184V was marginally associated with virologic success (HR: 1.34, 95% CI: 0.94–1.90, p = 0.10 vs no M184V), whilst the number of TAMs was not associated. One-hundred-thirty-three (54.3%) subjects achieved immunologic success (increase of ≥ 100 cells/mm3 from baseline) in a median time of 7.5 months; immunologic success was associated with HIV-RNA levels at baseline (HR: 0.91, 95% CI: 0.79–0.98, p = 0.04 for each additional log10 copies/ml), the total number of mutations either for PI or NNRTI (HR: 0.91, 95% CI: 0.85–0.98, p = 0.01 for each additional mutation) and CD4 count at baseline (HR: 1.11, 95% CI: 1.00–1.23, p = 0.05 for each additional 100 cells/mm3). Results obtained by the on-treatment analyses were comparable. In our study, HAART containing TDF/ddI seem associated with a virologic and immunologic response, when such regimens are chosen according to a genotypic resistance test. [ABSTRACT FROM AUTHOR]

Published
2007
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6. Observational study on HIV-infected subjects failing HAART receiving tenofovir plus didanosine as NRTI backbone

Author

A. De Luca, Cristina Mussini, Elisabetta Chiesa, Antonella Castagna, A. Matti, Carlo Torti, C. Abeli, Nicola Gianotti, Paola Cicconi, A d'Arminio Monforte, Marco Bongiovanni, Amedeo Capetti, Mauro Zaccarelli, A. Di Biagio, Andrea Antinori, Patrizia Marconi, Valeria Tirelli, Paola Nasta, Francesca Gatti, Bongiovanni, M., Gianotti, N., Chiesa, E., Nasta, P., Cicconi, P., Capetti, A., Di Biagio, A., Matti, A., Tirelli, V., Marconi, P., De Luca, A., Mussini, C., Gatti, F., Zaccarelli, M., Abeli, C., Torti, C., Antinori, A., Castagna, Antonella, and D'arminio Monforte, A.

Subjects
Male, Enfuvirtide, Drug Resistance, HIV Infections, Pharmacology, Gastroenterology, chemistry.chemical_compound, Retrospective Studie, Abacavir, Organophosphonate, Antiretroviral Therapy, Highly Active, Hiv infected, HIV Infection, Viral, Didanosine, virus diseases, General Medicine, Middle Aged, Resistance mutation, Reverse Transcriptase Inhibitor, AIDS, Infectious Diseases, Treatment Outcome, Combination, Reverse Transcriptase Inhibitors, Drug Therapy, Combination, Female, Sequence Analysis, Human, medicine.drug, Microbiology (medical), Adult, medicine.medical_specialty, Efavirenz, Adenine, Anti-HIV Agents, CD4 Lymphocyte Count, DNA, Viral, Drug Resistance, Viral, HIV-1, Humans, Mutation, Organophosphonates, Retrospective Studies, Sequence Analysis, DNA, Tenofovir, Antiretroviral Therapy, HIV, tenofovir, Drug Therapy, Internal medicine, medicine, Highly Active, business.industry, Anti-HIV Agent, DNA, chemistry, Observational study, business
Abstract

We evaluated the efficacy of tenofovir (TDF) - and didanosine (ddI)-containing backbones in HIV-infected experienced subjects. We included in the study 245 subjects who started a TDF/ddI-containing HAART with HIV-RNA > 3 log10cp/ml and an available genotypic resistance test at baseline. At baseline, median CD4 counts and HIV-RNA were 278 cell/mmc and 4.32 log10cp/ml, respectively. Seventy-four subjects (30.2%) discontinued TDF and/or ddI, 23 of them for drug-related toxicities or intolerance. One-hundred and twenty-six (51.4%) subjects achieved virologic success (HIV-RNA < 50 copies/ml in two consecutive determinations) in a median time of 6.1 months; higher HIV-RNA levels (HR: 0.66, 95% CI: 0.54- 0.79, p < 0.001 for each additional log10copies/ml), and the total number of mutations either for PI and NNRTI at baseline (HR: 0.87, 95% CI: 0.81-0.92, p < 0.001 for each additional mutation) were both predictors of virologic success. M184V was marginally associated with virologic success (HR: 1.34, 95% CI: 0.94-1.90, p = 0.10 vs no M184V), whilst the number of TAMs was not associated. One-hundred-thirty-three (54.3%) subjects achieved immunologic success (increase of ≥ 100 cells/mm3from baseline) in a median time of 7.5 months; immunologic success was associated with HIV-RNA levels at baseline (HR: 0.91, 95% CI: 0.79-0.98, p = 0.04 for each additional log10copies/ml), the total number of mutations either for PI or NNRTI (HR: 0.91, 95% CI: 0.85-0.98, p = 0.01 for each additional mutation) and CD4 count at baseline (HR: 1.11, 95% CI: 1.00-1.23, p = 0.05 for each additional 100 cells/mm3). Results obtained by the on-treatment analyses were comparable. In our study, HAART containing TDF/ddI seem associated with a virologic and immunologic response, when such regimens are chosen according to a genotypic resistance test. © 2007 Urban & Vogel.

Published
2007

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