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

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

Tracking Information

• First Submitted Date: February 9, 2009
• First Posted Date: February 10, 2009
• Last Update Posted Date: January 26, 2010
• Study Start Date: March 2009
• Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Diagnostic

Condition

• HIV-1
• HIV Infections

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 9, 2009): 756
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2012
• Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00840762
• Other Study ID Numbers: 07-118
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: David E. Barker, MD, The Ruth M. Rothstein CORE Center of Cook County
• Study Sponsor: Ruth M. Rothstein CORE Center
• Collaborators: Virco

Investigators

• Principal Investigator: David E Barker, MD; Ruth M. Rothstein CORE Center

• PRS Account: Ruth M. Rothstein CORE Center
• Verification Date: January 2010