Fold-change Resistance Clinical Trial
Official title:
GePheRal: Clinical Validation of the Genotypic Diagnosis of Hiv-1 Resistance to Raltegravir by Parallel Analysis of the Genotype and Phenotype Profiles of Resistance
The purpose of this study is to correlate the different patterns of resistance mutations observed in vivo in patients failing RAL treatment with the fold-change resistance determined by the phenotypic assay.
The secondary objectives are, as follows:
- to establish standardised genotypic assay for the HIV-1 pol gene region (region of
interest, sensitivity, mutations involved as primary or compensatory changes, role of
polymorphism present at baseline).
- to reach consensus on the algorithm interpretation of in house ex-vivo genotypic
evaluations.
- to assess the genetic changes in RAL-failing patients under continuous drug pressure or
drug discontinuation (dynamics of the reversion of resistance mutations).
- to evaluate in RAL resistant HIV-1 variants the changes in replication capacity (RC)
(baseline vs. following-timepoints).
- to evaluate the immunological and virological trend associated with a
raltegravir-regimen failure.
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Observational Model: Case-Only, Time Perspective: Prospective