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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00840762
Other study ID # 07-118
Secondary ID
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


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
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