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



Sponsors


Source

Università Vita-Salute San Raffaele

Oversight Info

Has Dmc

No


Brief Summary

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.

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.

Overall Status

Unknown status

Start Date

2011-12-01

Completion Date

2013-09-01

Primary Completion Date

2013-03-01

Study Type

Observational

Primary Outcome

Measure

Time Frame

- mean value of fold-change resistance determined by the phenotypic assay at baseline
baseline

Secondary Outcome

Measure

Time Frame

changes of fold-change resistance determined by the phenotypic assay with respect to baseline.
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)
24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.
changes of the replication capacity with respect to baseline
24 and 48 hours, W1, W2, W3 and W4 upon discontinuation.
changes of HIV-RNA with respect to baseline
24 and 48 hours, W1, W2, W3 and W4 upon discontinuation
changes in CD4, CD4%, CD8, CD8% with respect to baseline
24 and 48 hours, W1, W2, W3 and W4 upon discontinuation

Number Of Groups

1

Enrollment

100

Conditions


Eligibility

Study Pop

primary care clinic

Sampling Method

Non-Probability Sample

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:

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Massimo Clementi, Prof.
Principal Investigator
University Vita-Salute San Raffaele Laboratory of Microbiology and Virology
Antonella Castagna, MD
Study Director
Department of Infectious Diseases, IRCCS San Raffaele Hospital

Overall Contact

Last Name

Antonella Castagna, MD

Phone

0039022643

Phone Ext

7934

Email

castagna.antonella@hsr.it


Location

Facility

Status

Contact

Investigator

Department of Infectious Diseases, IRCCS San Raffaele Hospital
Milan 20127 Italy
Recruiting
Last Name: Antonella Castagna, MD
Phone: 0039022643
Phone Ext: 7934
Email: castagna.antonella@hsr.it
Last Name: Antonella Castagna, MD
Role: Principal Investigator

Last Name: Massimo Clementi, Prof.
Role: Principal Investigator


Location Countries

Country

Italy


Verification Date

2013-02-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Università Vita-Salute San Raffaele

Investigator Full Name

Elisabetta Carini

Investigator Title

Professor Massimo Clementi


Keywords


Has Expanded Access

No

Secondary Id

Merck Sharp & Dohme Corp.

Intervention Browse

Mesh Term

Raltegravir Potassium


Arm Group

Arm Group Label

RAL Group

Description

HIV-1 infected patients failing to a RALTEGRAVIR-containing regimen


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Elisabetta Carini, Msc

Phone

0039022643

Phone Ext

7934

Email

carini.elisabetta@hsr.it


Biospec Retention

Samples Without DNA

Biospec Descr

whole blood

Reference

Citation

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PMID

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PMID

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Citation

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PMID

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Citation

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PMID

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Citation

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PMID

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Citation

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Citation

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Citation

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Citation

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PMID

19221102



Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Case-Only

Time Perspective

Prospective


Study First Submitted

June 23, 2011

Study First Submitted Qc

June 24, 2011

Study First Posted

June 27, 2011

Last Update Submitted

February 8, 2013

Last Update Submitted Qc

February 8, 2013

Last Update Posted

February 11, 2013

Last Known Status

Recruiting


ClinicalTrials.gov processed this data on August 24, 2018

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Study Phase

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In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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