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

Università Vita-Salute San Raffaele

Status

Unknown

Conditions

Fold-change Resistance

Resistance Mutations

HIV-1 Infected Patients

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01381328

Merck Sharp & Dohme Corp. (Other Identifier)

Gepheral

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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