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

Sponsor:	Ruth M. Rothstein CORE Center
Collaborator:	Virco
Information provided by:	Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier:	NCT00840762

Purpose

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

Condition	Intervention	Phase
HIV-1 HIV Infections	Other: VircoType HIV-1 genotypic interpretation Other: Local Expert Review of HIV Genotypic resistance testing	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	A Randomized Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Ruth M. Rothstein CORE Center:

Primary Outcome Measures:

Proportion of patients with viral load <1000 60days after HIV regimen change [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Proportion of patients with viral load <1000 180 days after HIV regimen change [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with undetectable viral load 60days after HIV regimen change [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Proportion of patients with undetectable viral load 180days after HIV regimen change [ Time Frame: 180 days ] [ Designated as safety issue: No ]
CD4 Cell count change in each arm at 60 and 180 days [ Time Frame: 60 and 180 days ] [ Designated as safety issue: No ]
Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days [ Time Frame: 180 and 360 days ] [ Designated as safety issue: No ]
Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	756
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VircoType HIV-1 Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm	Other: VircoType HIV-1 genotypic interpretation VircoType HIV-1 genotypic interpretation
Active Comparator: Local Expert review Local Expert HIV genotypic review, as per Badri, S. et al CID 2003	Other: Local Expert Review of HIV Genotypic resistance testing Local Expert Review of HIV Genotypic resistance testing

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840762

Contacts

Contact: David E Barker, MD	312-572-4503	dbarker@corecenter.org
Contact: Karen Kroc, MPH	312-572-4765	kkroc@corecenter.org

Locations

United States, Illinois
The Ruth M. Rothstein CORE Center	Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: David E Barker, MD
Sub-Investigator: Harold A Kessler, MD
Sub-Investigator: Sheila M Badri, MD
Sub-Investigator: Blake Max, PharmD
Sub-Investigator: Kathleen G Beavis, MD

Sponsors and Collaborators

Ruth M. Rothstein CORE Center

Virco

Investigators

Principal Investigator:

David E Barker, MD

Ruth M. Rothstein CORE Center

More Information

Additional Information:

The CORE Center This link exits the ClinicalTrials.gov site

Cook County Hospital Department of Medicine This link exits the ClinicalTrials.gov site

Rush Medical Center Section of Infectious Diseases This link exits the ClinicalTrials.gov site

UIC College of Pharmacy This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2003 Aug 15.

Responsible Party:	David E. Barker, MD, The Ruth M. Rothstein CORE Center of Cook County
ClinicalTrials.gov Identifier:	NCT00840762 History of Changes
Other Study ID Numbers:	07-118
Study First Received:	February 9, 2009
Last Updated:	January 25, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Ruth M. Rothstein CORE Center:

HIV-1
HIV
HIV Genotypic testing
resistance

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012