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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Ruth M. Rothstein CORE Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Virco
Information provided by:
Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier:
NCT00840762
First received: February 9, 2009
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
HIV-1
HIV Infections
Other: VircoType HIV-1 genotypic interpretation
Other: Local Expert Review of HIV Genotypic resistance testing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomized Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication

Resource links provided by NLM:


Further study details as provided by Ruth M. Rothstein CORE Center:

Primary Outcome Measures:
  • Proportion of patients with viral load <1000 60days after HIV regimen change [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Proportion of patients with viral load <1000 180 days after HIV regimen change [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with undetectable viral load 60days after HIV regimen change [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Proportion of patients with undetectable viral load 180days after HIV regimen change [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • CD4 Cell count change in each arm at 60 and 180 days [ Time Frame: 60 and 180 days ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 756
Study Start Date: March 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VircoType HIV-1
Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm
Other: VircoType HIV-1 genotypic interpretation
VircoType HIV-1 genotypic interpretation
Active Comparator: Local Expert review
Local Expert HIV genotypic review, as per Badri, S. et al CID 2003
Other: Local Expert Review of HIV Genotypic resistance testing
Local Expert Review of HIV Genotypic resistance 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840762

Contacts
Contact: David E Barker, MD 312-572-4503 dbarker@corecenter.org
Contact: Karen Kroc, MPH 312-572-4765 kkroc@corecenter.org

Locations
United States, Illinois
The Ruth M. Rothstein CORE Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: David E Barker, MD         
Sub-Investigator: Harold A Kessler, MD         
Sub-Investigator: Sheila M Badri, MD         
Sub-Investigator: Blake Max, PharmD         
Sub-Investigator: Kathleen G Beavis, MD         
Sponsors and Collaborators
Ruth M. Rothstein CORE Center
Virco
Investigators
Principal Investigator: David E Barker, MD Ruth M. Rothstein CORE Center
  More Information

Additional Information:
Publications:
Responsible Party: David E. Barker, MD, The Ruth M. Rothstein CORE Center of Cook County
ClinicalTrials.gov Identifier: NCT00840762     History of Changes
Other Study ID Numbers: 07-118
Study First Received: February 9, 2009
Last Updated: January 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ruth M. Rothstein CORE Center:
HIV-1
HIV
HIV Genotypic testing
resistance

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014