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

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ClinicalTrials.gov Identifier: NCT00840762
Recruitment Status : Unknown
Verified January 2010 by Ruth M. Rothstein CORE Center.
Recruitment status was:  Recruiting
First Posted : February 10, 2009
Last Update Posted : January 26, 2010
Sponsor:
Collaborator:
Virco
Information provided by:
Ruth M. Rothstein CORE Center

Tracking Information
First Submitted Date  ICMJE February 9, 2009
First Posted Date  ICMJE February 10, 2009
Last Update Posted Date January 26, 2010
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
  • Proportion of patients with viral load <1000 60days after HIV regimen change [ Time Frame: 60 days ]
  • Proportion of patients with viral load <1000 180 days after HIV regimen change [ Time Frame: 180 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
  • Proportion of patients with undetectable viral load 60days after HIV regimen change [ Time Frame: 60 days ]
  • Proportion of patients with undetectable viral load 180days after HIV regimen change [ Time Frame: 180 days ]
  • CD4 Cell count change in each arm at 60 and 180 days [ Time Frame: 60 and 180 days ]
  • Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days [ Time Frame: 180 and 360 days ]
  • Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed [ Time Frame: 180 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
Official Title  ICMJE A Randomized Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • HIV-1
  • HIV Infections
Intervention  ICMJE
  • Other: VircoType HIV-1 genotypic interpretation
    VircoType HIV-1 genotypic interpretation
  • Other: Local Expert Review of HIV Genotypic resistance testing
    Local Expert Review of HIV Genotypic resistance testing
Study Arms  ICMJE
  • Experimental: VircoType HIV-1
    Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm
    Intervention: Other: VircoType HIV-1 genotypic interpretation
  • Active Comparator: Local Expert review
    Local Expert HIV genotypic review, as per Badri, S. et al CID 2003
    Intervention: Other: Local Expert Review of HIV Genotypic resistance testing
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 9, 2009)
756
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00840762
Other Study ID Numbers  ICMJE 07-118
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David E. Barker, MD, The Ruth M. Rothstein CORE Center of Cook County
Study Sponsor  ICMJE Ruth M. Rothstein CORE Center
Collaborators  ICMJE Virco
Investigators  ICMJE
Principal Investigator: David E Barker, MD Ruth M. Rothstein CORE Center
PRS Account Ruth M. Rothstein CORE Center
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP