A randomized controlled trial to evaluate antiretroviral salvage therapy guided by rules-based or phenotype-driven HIV-1 genotypic drug-resistance interpretation with or without concentration-controlled intervention: The resistance and dosage adapted regimens (RADAR) study

Carlo Torti, Eugenia Quiros-Roldan, Mario Regazzi, Andrea De Luca, Francesco Mazzotta, Andrea Antinori, Nicoleda Ladisa, Valeria Micheli, Anna Orani, Andrea Patroni, Paola Villani, Sergio Lo Caputo, Francesca Moretti, Simona Di Giambenedetto, Filippo Castelnuovo, Paolo Maggi, Carmine Tinelli, Giampiero Carosi

Research output: Contribution to journalArticlepeer-review

Abstract

Background. It is not well defined whether concentration-controlled intervention (CCI) and rules-based human immunodeficiency virus (HIV) type 1 genotype drug-resistance interpretation (GI) or virtual phenotype drug-resistance interpretation (VPI) may improve the outcome of HIV salvage therapy. Methods. In a prospective, randomized, controlled trial, patients were randomized (on a factorial basis) to change treatment after either GI or VPI, and they then were further randomized to the control arm (no CCI) or the CCI arm. Protease inhibitor (PI) and nonnucleoside reverse-transcriptase inhibitor (NNRTI) trough concentration (Ctrough) values were determined at weeks 1, 4, 12, and 24 of the study. Results. Among 230 patients, virological benefit (defined by an HIV RNA load of trough value and/or an NNRTI Ctrough value in the higher quartiles (or above cutoff levels) and a low number of PIs previously received. Moreover, receipt of a regimen that contained PIs boosted with ritonavir was an independent predictor of virological response. Conclusions. The present study did not support the routine use of CCI for patients undergoing salvage treatment, probably as a result of existing difficulties associated with its clinical application. However, a higher Ctrough value appeared to be correlated with treatment response. No major differences were found between VPI or GI when they are used together with expert advice for the selection of salvage treatment combinations.

Original languageEnglish
Pages (from-to)1828-1836
Number of pages9
JournalClinical Infectious Diseases
Volume40
Issue number12
DOIs
Publication statusPublished - Jun 15 2005

ASJC Scopus subject areas

  • Immunology

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