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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00840762
• Other study ID #: 07-118
• Status: Recruiting
• Phase: Phase 4
• First received: February 9, 2009
• Last updated: January 25, 2010
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: January 2010
• Source: Ruth M. Rothstein CORE Center
• Contact: David E Barker, MD
• Phone: 312-572-4503
• Email: dbarker[@]corecenter.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 756
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• HIV Infections
• HIV-1

Intervention

Other:
• VircoType HIV-1 genotypic interpretation
VircoType HIV-1 genotypic interpretation
• Local Expert Review of HIV Genotypic resistance testing
Local Expert Review of HIV Genotypic resistance testing

Locations

Country	Name	City	State
United States	The Ruth M. Rothstein CORE Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ruth M. Rothstein CORE Center	Virco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with viral load <1000 60days after HIV regimen change		60 days	No
Primary	Proportion of patients with viral load <1000 180 days after HIV regimen change		180 days	No
Secondary	Proportion of patients with undetectable viral load 60days after HIV regimen change		60 days	No
Secondary	Proportion of patients with undetectable viral load 180days after HIV regimen change		180 days	No
Secondary	CD4 Cell count change in each arm at 60 and 180 days		60 and 180 days	No
Secondary	Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days		180 and 360 days	No
Secondary	Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed		180 days	No

External Links

•   Rush Medical Center Section of Infectious Diseases
•   The CORE Center
•   UIC College of Pharmacy