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

Phase 4

• Conditions: HIV-1; HIV Infections
• Interventions: Other: VircoType HIV-1 genotypic interpretation; Other: Local Expert Review of HIV Genotypic resistance testing

• Registration Number: NCT00840762
• Lead Sponsor: Ruth M. Rothstein CORE Center

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.

Study Timeline

• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Study Start: 2009-03
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-25
• Last Update Posted: 2010-01-26
• Primary Completion: 2012-02
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 756

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VircoType HIV-1	VircoType HIV-1 genotypic interpretation	Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm
Local Expert review	Local Expert Review of HIV Genotypic resistance testing	Local Expert HIV genotypic review, as per Badri, S. et al CID 2003

Primary Outcome Measures

Name	Time	Method
Proportion of patients with viral load <1000 180 days after HIV regimen change	180 days
Proportion of patients with viral load <1000 60days after HIV regimen change	60 days

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

The Ruth M. Rothstein CORE Center; 🇺🇸 Chicago, Illinois, United States