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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV-1 Infected Patients, Fold-change Resistance, Resistance Mutations

Participation Criteria
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Eligibility Criteria
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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: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RAL Group<br>HIV-1 infected patients failing to a RALTEGRAVIR-containing regimen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - mean value of fold-change resistance determined by the phenotypic assay at baseline |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| changes in CD4, CD4%, CD8, CD8% with respect to baseline |  | 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1 infected patients, RALTEGRAVIR regimen, genotypic evaluations, phenotypic evaluations