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

Nicola Gianotti, Vincenzo Mondino, Maria Cristina Rossi, Elisabetta Chiesa, Ivano Mezzaroma, Nicoletta Ladisa, Giovanni Guaraldi, Carlo Torti, Pierluigi Tarquini, Paula Castelli, Aldo Di Carlo, Enzo Boeri, Wilco Keulen, Paula McKenna, Adriano Lazzarin

Research output: Contribution to journalArticle

7 Citations (Scopus)

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 10 copies/mL; CD4 + T lymphocyte count, 410 ± 262 cells/μL; 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

Original languageEnglish
Pages (from-to)1470-1480
Number of pages11
JournalClinical Infectious Diseases
Volume42
Issue number10
DOIs
Publication statusPublished - May 15 2006

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Reverse Transcriptase Inhibitors
Randomized Controlled Trials
Genotype
HIV
Phenotype
Mutation
Protease Inhibitors
RNA
Italy
RNA-Directed DNA Polymerase
CD4 Lymphocyte Count
Nucleosides
Pharmaceutical Preparations
Uncertainty
Peptide Hydrolases
History
T-Lymphocytes
Therapeutics

ASJC Scopus subject areas

  • Immunology

Cite this

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. / Gianotti, Nicola; Mondino, Vincenzo; Rossi, Maria Cristina; Chiesa, Elisabetta; Mezzaroma, Ivano; Ladisa, Nicoletta; Guaraldi, Giovanni; Torti, Carlo; Tarquini, Pierluigi; Castelli, Paula; Di Carlo, Aldo; Boeri, Enzo; Keulen, Wilco; McKenna, Paula; Lazzarin, Adriano.

In: Clinical Infectious Diseases, Vol. 42, No. 10, 15.05.2006, p. 1470-1480.

Research output: Contribution to journalArticle

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, McKenna, P & Lazzarin, A 2006, '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', Clinical Infectious Diseases, vol. 42, no. 10, pp. 1470-1480. https://doi.org/10.1086/503568
Gianotti, Nicola ; Mondino, Vincenzo ; Rossi, Maria Cristina ; Chiesa, Elisabetta ; Mezzaroma, Ivano ; Ladisa, Nicoletta ; Guaraldi, Giovanni ; Torti, Carlo ; Tarquini, Pierluigi ; Castelli, Paula ; Di Carlo, Aldo ; Boeri, Enzo ; Keulen, Wilco ; McKenna, Paula ; Lazzarin, Adriano. / 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. In: Clinical Infectious Diseases. 2006 ; Vol. 42, No. 10. pp. 1470-1480.
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AU - Di Carlo, Aldo

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