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

Brief Summary

Official Title: “A Randomized Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
  • Study Primary Completion Date: February 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: VircoType HIV-1
    • Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm
  • Active Comparator: Local Expert review
    • Local Expert HIV genotypic review, as per Badri, S. et al CID 2003

Outcome Measures for this Clinical Trial

Primary Measures

  • Proportion of patients with viral load <1000 60days after HIV regimen change
    • Time Frame: 60 days
      Safety Issue?: No
  • Proportion of patients with viral load <1000 180 days after HIV regimen change
    • Time Frame: 180 days
      Safety Issue?: No

Secondary Measures

  • Proportion of patients with undetectable viral load 60days after HIV regimen change
    • Time Frame: 60 days
      Safety Issue?: No
  • Proportion of patients with undetectable viral load 180days after HIV regimen change
    • Time Frame: 180 days
      Safety Issue?: No
  • CD4 Cell count change in each arm at 60 and 180 days
    • Time Frame: 60 and 180 days
      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
      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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Ruth M. Rothstein CORE Center
  • Collaborator
    • Virco
  • Provider of Information About this Clinical Study
    • David E. Barker, MD, The Ruth M. Rothstein CORE Center of Cook County
  • Overall Official(s)
    • David E Barker, MD, Principal Investigator, Ruth M. Rothstein CORE Center
  • Overall Contact(s)
    • David E Barker, MD, 312-572-4503, dbarker@corecenter.org

References

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.

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00840762