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A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication

NCT ID: NCT00840762

Last Updated: 2010-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-07-31

Brief Summary

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The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review. The investigators propose that clinic patients of the Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time point equal to or greater than 2 months and 6 months following the change in antiretroviral medications following the testing

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Detailed Description

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Patients having some documented genotypic HIV resistance but having more than one fully active medication will be randomized to either local review or algorithmic review by VircoType HIV-1.

Conditions

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HIV-1 HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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VircoType HIV-1

Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm

Group Type EXPERIMENTAL

VircoType HIV-1 genotypic interpretation

Intervention Type OTHER

VircoType HIV-1 genotypic interpretation

Local Expert review

Local Expert HIV genotypic review, as per Badri, S. et al CID 2003

Group Type ACTIVE_COMPARATOR

Local Expert Review of HIV Genotypic resistance testing

Intervention Type OTHER

Local Expert Review of HIV Genotypic resistance testing

Interventions

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VircoType HIV-1 genotypic interpretation

VircoType HIV-1 genotypic interpretation

Intervention Type OTHER

Local Expert Review of HIV Genotypic resistance testing

Local Expert Review of HIV Genotypic resistance testing

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HIV resistance testing that demonstrates resistance to at least one drug
* Patients of the CORE Center, Chicago Illinois

Exclusion Criteria

* Wild type HIV on resistance testing or less than or equal to one active antiretroviral medication
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virco

INDUSTRY

Sponsor Role collaborator

Ruth M. Rothstein CORE Center

OTHER

Sponsor Role lead

Responsible Party

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The Ruth M. Rothstein CORE Center of Cook County

Principal Investigators

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David E Barker, MD

Role: PRINCIPAL_INVESTIGATOR

Ruth M. Rothstein CORE Center

Locations

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The Ruth M. Rothstein CORE Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David E Barker, MD

Role: CONTACT

[email protected]
312-572-4503

Karen Kroc, MPH

Role: CONTACT

[email protected]
312-572-4765

References

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Badri SM, Adeyemi OM, Max BE, Zagorski BM, Barker DE. How does expert advice impact genotypic resistance testing in clinical practice? Clin Infect Dis. 2003 Sep 1;37(5):708-13. doi: 10.1086/377266. Epub 2003 Aug 15.

Reference Type BACKGROUND
PMID: 12942405 (View on PubMed)

Related Links

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http://www.corecenter.org/

The CORE Center

http://www.uic.edu/pharmacy/about_the_college/index.php

UIC College of Pharmacy

Other Identifiers

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07-118

Identifier Type: -

Identifier Source: org_study_id

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