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: HIV-1 Infected Patients; Resistance Mutations; Fold-change Resistance

• Registration Number: NCT01381328
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Study Timeline

• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Study Start: 2011-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11
• Primary Completion: 2013-03
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- mean value of fold-change resistance determined by the phenotypic assay at baseline	baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Infectious Diseases, IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy