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

February 8, 2013 updated by: Elisabetta Carini, Università Vita-Salute San Raffaele
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.

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Milan, Italy, 20127
        • Recruiting
        • Department of Infectious Diseases, IRCCS San Raffaele Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonella Castagna, MD
        • Principal Investigator:
          • Massimo Clementi, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
RAL Group
HIV-1 infected patients failing to a RALTEGRAVIR-containing regimen

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.
24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.
changes of the replication capacity with respect to baseline
Time Frame: 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.
24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.
changes of HIV-RNA with respect to baseline
Time Frame: 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation
24 and 48 hours, W1, W2, W3 and W4 upon discontinuation
changes in CD4, CD4%, CD8, CD8% with respect to baseline
Time Frame: 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation
24 and 48 hours, W1, W2, W3 and W4 upon discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • Gepheral
  • Merck Sharp & Dohme Corp. (Other Identifier: Merck Sharp & Dohme Corp.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV-1 Infected Patients

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