NCT01381328

GePheRal: Clinical Validation of the Genotypic Diagnosis of Hiv-1 Resistance to Raltegravir by Parallel Analysis of the Genotype and Phenotype Profiles of Resistance

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV-1 Infected Patients
• Fold-change Resistance
• Resistance Mutations

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-03-01
• Completion: 2013-09-01
• First posted: 2011-06-27
• Last updated: 2013-02-11

Locations

1 site across 1 country: Italy