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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01381328

Enrollment

100

Registered

2011-06-27

Start date

2011-12-31

Completion date

2013-09-30

Last updated

2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HIV-1 infected patients, RALTEGRAVIR regimen, genotypic evaluations, phenotypic evaluations

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
- mean value of fold-change resistance determined by the phenotypic assay at baseline	baseline

Secondary

Measure	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

Countries

Italy

Contacts

Primary ContactAntonella Castagna, MD

castagna.antonella@hsr.it0039022643

Backup ContactElisabetta Carini, Msc

carini.elisabetta@hsr.it0039022643

Outcome results