NCT00840762

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 756 (estimated)
• Sponsor: Ruth M. Rothstein CORE Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1
• HIV Infections

Interventions

Type	Name	Description
OTHER	VircoType HIV-1 genotypic interpretation	VircoType HIV-1 genotypic interpretation
OTHER	Local Expert Review of HIV Genotypic resistance testing	Local Expert Review of HIV Genotypic resistance testing

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-02-01
• Completion: 2012-07-01
• First posted: 2009-02-10
• Last updated: 2010-01-26

Locations

1 site across 1 country: United States