Recruiting

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

Sponsor:

Ruth M. Rothstein CORE Center

Code:

NCT00840762

Conditions

HIV-1

HIV Infections

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

VircoType HIV-1 genotypic interpretation

Local Expert Review of HIV Genotypic resistance testing

Study Details

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

Conditions

HIV-1

HIV Infections

Study ID

NCT00840762

Start date

Mar, 2009

Status verified date

Jan, 2010

Completion date

Jul, 2012

Anticipated

Primary completion date

Feb, 2012

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

756 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: VircoType HIV-1

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

active comparator: Local Expert review

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

Interventions

VircoType HIV-1 genotypic interpretation

Local Expert Review of HIV Genotypic resistance testing

Primary outcome measure

Proportion of patients with viral load <1000 60days after HIV regimen change [ Time Frame: 60 days ]
Proportion of patients with viral load <1000 180 days after HIV regimen change [ Time Frame: 180 days ]

Central Contacts and Locations

Central contacts

David E Barker, MD

312-572-4503 dbarker@corecenter.org

Karen Kroc, MPH

312-572-4765 kkroc@corecenter.org

Locations

The Ruth M. Rothstein CORE Center

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

David E Barker, MD

More Information

Sponsor

Ruth M. Rothstein CORE Center

Last update posted

Jan 26, 2010

Last verified

Jan, 2010

Keywords

HIV-1
HIV
HIV Genotypic testing
resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ruth M. Rothstein CORE Center on 2010-01-26.