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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014