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

This study is currently recruiting participants.
Verified February 2013 by Università Vita-Salute San Raffaele
Sponsor:
Collaborators:
IRCCS San Raffaele
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Elisabetta Carini, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01381328
First received: June 23, 2011
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: GePheRal: Clinical Validation of the Genotypic Diagnosis of Hiv-1 Resistance to Raltegravir by Parallel Analysis of the Genotype and Phenotype Profiles of Resistance

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • - mean value of fold-change resistance determined by the phenotypic assay at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes of fold-change resistance determined by the phenotypic assay with respect to baseline. [ Time Frame: 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation ] [ Designated as safety issue: No ]
  • genetic changes under continuous drug pressure or drug discontinuation with respect to baseline(dynamics of the reversion of resistance mutations) [ Time Frame: 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation. ] [ Designated as safety issue: No ]
  • changes of the replication capacity with respect to baseline [ Time Frame: 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation. ] [ Designated as safety issue: No ]
  • changes of HIV-RNA with respect to baseline [ Time Frame: 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation ] [ Designated as safety issue: No ]
  • changes in CD4, CD4%, CD8, CD8% with respect to baseline [ Time Frame: 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
RAL Group
HIV-1 infected patients failing to a RALTEGRAVIR-containing regimen

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381328

Contacts
Contact: Antonella Castagna, MD 0039022643 ext 7934 castagna.antonella@hsr.it
Contact: Elisabetta Carini, Msc 0039022643 ext 7934 carini.elisabetta@hsr.it

Locations
Italy
Department of Infectious Diseases, IRCCS San Raffaele Hospital Recruiting
Milan, Italy, 20127
Contact: Antonella Castagna, MD    0039022643 ext 7934    castagna.antonella@hsr.it   
Contact: Elisabetta Carini, MSc    0039022643 ext 7934    carini.elisabetta@hsr.it   
Principal Investigator: Antonella Castagna, MD         
Principal Investigator: Massimo Clementi, Prof.         
Sponsors and Collaborators
Università Vita-Salute San Raffaele
IRCCS San Raffaele
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Massimo Clementi, Prof. University Vita-Salute San Raffaele Laboratory of Microbiology and Virology
Study Director: Antonella Castagna, MD Department of Infectious Diseases, IRCCS San Raffaele Hospital
  More Information

Publications:

Responsible Party: Elisabetta Carini, Professor Massimo Clementi, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01381328     History of Changes
Other Study ID Numbers: Gepheral, Merck Sharp & Dohme Corp.
Study First Received: June 23, 2011
Last Updated: February 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Università Vita-Salute San Raffaele:
HIV-1 infected patients
RALTEGRAVIR regimen
genotypic evaluations
phenotypic evaluations

ClinicalTrials.gov processed this record on April 17, 2014