Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 23, 2011
February 8, 2013
December 2011
March 2013   (final data collection date for primary outcome measure)
- mean value of fold-change resistance determined by the phenotypic assay at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01381328 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
GePheRal: Clinical Validation of the Genotypic Diagnosis of Hiv-1 Resistance to Raltegravir by Parallel Analysis of the Genotype and Phenotype Profiles of Resistance
GePheRal: Clinical Validation of the Genotypic Diagnosis of Hiv-1 Resistance to Raltegravir by Parallel Analysis of the Genotype and Phenotype Profiles of Resistance

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood

Non-Probability Sample

primary care clinic

  • HIV-1 Infected Patients
  • Fold-change Resistance
  • Resistance Mutations
Not Provided
RAL Group
HIV-1 infected patients failing to a RALTEGRAVIR-containing regimen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Antonella Castagna, MD 0039022643 ext 7934 castagna.antonella@hsr.it
Contact: Elisabetta Carini, Msc 0039022643 ext 7934 carini.elisabetta@hsr.it
Italy
 
NCT01381328
Gepheral, Merck Sharp & Dohme Corp.
No
Elisabetta Carini, Università Vita-Salute San Raffaele
Università Vita-Salute San Raffaele
  • IRCCS San Raffaele
  • Merck Sharp & Dohme Corp.
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
Università Vita-Salute San Raffaele
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP