A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
A Randomized Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
1 other identifier
interventional
756
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJanuary 26, 2010
January 1, 2010
2.9 years
February 9, 2009
January 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of patients with viral load <1000 60days after HIV regimen change
60 days
Proportion of patients with viral load <1000 180 days after HIV regimen change
180 days
Secondary Outcomes (5)
Proportion of patients with undetectable viral load 60days after HIV regimen change
60 days
Proportion of patients with undetectable viral load 180days after HIV regimen change
180 days
CD4 Cell count change in each arm at 60 and 180 days
60 and 180 days
Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days
180 and 360 days
Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed
180 days
Study Arms (2)
VircoType HIV-1
EXPERIMENTALGenotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm
Local Expert review
ACTIVE COMPARATORLocal Expert HIV genotypic review, as per Badri, S. et al CID 2003
Interventions
VircoType HIV-1 genotypic interpretation
Local Expert Review of HIV Genotypic resistance testing
Eligibility Criteria
You may qualify if:
- HIV resistance testing that demonstrates resistance to at least one drug
- Patients of the CORE Center, Chicago Illinois
You may not qualify if:
- Wild type HIV on resistance testing or less than or equal to one active antiretroviral medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruth M. Rothstein CORE Centerlead
- Vircocollaborator
Study Sites (1)
The Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612, United States
Related 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. doi: 10.1086/377266. Epub 2003 Aug 15.
PMID: 12942405BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David E Barker, MD
Ruth M. Rothstein CORE Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
March 1, 2009
Primary Completion
February 1, 2012
Study Completion
July 1, 2012
Last Updated
January 26, 2010
Record last verified: 2010-01