HIV-1, HIV Infections
Conditions
Keywords
HIV-1, HIV, HIV Genotypic testing, resistance
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.
Interventions
OTHERVircoType HIV-1 genotypic interpretation
VircoType HIV-1 genotypic interpretation
OTHERLocal Expert Review of HIV Genotypic resistance testing
Local Expert Review of HIV Genotypic resistance testing
Sponsors
Virco
Ruth M. Rothstein CORE Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| CD4 Cell count change in each arm at 60 and 180 days | 60 and 180 days |
| Proportion of patients with undetectable viral load 60days after HIV regimen change | 60 days |
| Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed | 180 days |
| Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days | 180 and 360 days |
| Proportion of patients with undetectable viral load 180days after HIV regimen change | 180 days |
Countries
United States
Contacts
Primary ContactDavid E Barker, MD
Backup ContactKaren Kroc, MPH
Outcome results
None listed