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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV-1, HIV Infections

Intervention / Treatment
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* Other: VircoType HIV-1 genotypic interpretation
* Other: Local Expert Review of HIV Genotypic resistance testing


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VircoType HIV-1<br>Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm | Other: VircoType HIV-1 genotypic interpretation<br>* VircoType HIV-1 genotypic interpretation<br>|
| Active Comparator: Local Expert review<br>Local Expert HIV genotypic review, as per Badri, S. et al CID 2003 | Other: Local Expert Review of HIV Genotypic resistance testing<br>* Local Expert Review of HIV Genotypic resistance testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with viral load <1000 60days after HIV regimen change |  | 60 days | 
| Proportion of patients with viral load <1000 180 days after HIV regimen change |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with undetectable viral load 60days after HIV regimen change |  | 60 days | 
| Proportion of patients with undetectable viral load 180days after HIV regimen change |  | 180 days | 
| CD4 Cell count change in each arm at 60 and 180 days |  | 60 and 180 days | 
| Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days |  | 180 and 360 days | 
| Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, HIV Genotypic testing, resistance, HIV