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

Ruth M. Rothstein CORE Center

Status and phase: Unknown; Phase 4

Conditions: HIV-1; HIV Infections

Treatments: Other: VircoType HIV-1 genotypic interpretation; Other: Local Expert Review of HIV Genotypic resistance testing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00840762

07-118

Details and patient eligibility

About

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

Full 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.

Enrollment: 756 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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756 participants in 2 patient groups

VircoType HIV-1

Experimental group

Description:

Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm

Treatment:

Other: VircoType HIV-1 genotypic interpretation

Local Expert review

Active Comparator group

Description:

Local Expert HIV genotypic review, as per Badri, S. et al CID 2003

Treatment:

Other: Local Expert Review of HIV Genotypic resistance testing