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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:
Information provided by:

Study Description
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

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : March 2009
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients with viral load <1000 60days after HIV regimen change [ Time Frame: 60 days ]
  2. Proportion of patients with viral load <1000 180 days after HIV regimen change [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Proportion of patients with undetectable viral load 60days after HIV regimen change [ Time Frame: 60 days ]
  2. Proportion of patients with undetectable viral load 180days after HIV regimen change [ Time Frame: 180 days ]
  3. CD4 Cell count change in each arm at 60 and 180 days [ Time Frame: 60 and 180 days ]
  4. Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days [ Time Frame: 180 and 360 days ]
  5. Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed [ Time Frame: 180 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: January 26, 2010
Last Verified: January 2010

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

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