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| Name | Class |
|---|---|
| Virco | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VircoType HIV-1 | Experimental | Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm |
|
| Local Expert review | Active Comparator | Local Expert HIV genotypic review, as per Badri, S. et al CID 2003 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VircoType HIV-1 genotypic interpretation | Other | VircoType HIV-1 genotypic interpretation |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David E Barker, MD | Contact | 312-572-4503 | dbarker@corecenter.org | |
| Karen Kroc, MPH | Contact | 312-572-4765 | kkroc@corecenter.org |
| Name | Affiliation | Role |
|---|---|---|
| David E Barker, MD | Ruth M. Rothstein CORE Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ruth M. Rothstein CORE Center | Recruiting | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12942405 | Background | 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. doi: 10.1086/377266. Epub 2003 Aug 15. |
| Label | URL |
|---|---|
| The CORE Center | View source |
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| Local Expert Review of HIV Genotypic resistance testing | Other | Local Expert Review of HIV Genotypic resistance testing |
|
| 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 |
| Cook County Hospital Department of Medicine | View source |
| UIC College of Pharmacy | View source |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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