GePheRal: Clinical Validation of the Genotypic Diagnosis of Hiv-1 Resistance to Raltegravir by Parallel Analysis of the Genotype and Phenotype Profiles of Resistance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV-1 Infected Patients
- Sponsor
- Università Vita-Salute San Raffaele
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- - mean value of fold-change resistance determined by the phenotypic assay at baseline
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Elisabetta Carini
Professor Massimo Clementi
Università Vita-Salute San Raffaele
Eligibility Criteria
Inclusion Criteria
- •Adult (at least 18 years of age) treatment-experienced, HIV-infected subjects of either sex and of any race, failing to a RAL-containing regimen will be enrolled in the study
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
- mean value of fold-change resistance determined by the phenotypic assay at baseline
Time Frame: baseline
Secondary Outcomes
- changes of fold-change resistance determined by the phenotypic assay with respect to baseline.(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation)
- genetic changes under continuous drug pressure or drug discontinuation with respect to baseline(dynamics of the reversion of resistance mutations)(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.)
- changes in CD4, CD4%, CD8, CD8% with respect to baseline(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation)
- changes of the replication capacity with respect to baseline(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.)
- changes of HIV-RNA with respect to baseline(24 and 48 hours, W1, W2, W3 and W4 upon discontinuation)