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

NCT00840762 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2010-01-26

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Virco

    collaborator INDUSTRY
  • Ruth M. Rothstein CORE Center

    lead OTHER

Principal Investigators

  • David E Barker, MD · Ruth M. Rothstein CORE Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-02-29
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00840762 on ClinicalTrials.gov