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

January 25, 2010 updated by: Ruth M. Rothstein CORE Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

756

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • The Ruth M. Rothstein CORE Center
        • Principal Investigator:
          • David E Barker, MD
        • Sub-Investigator:
          • Harold A Kessler, MD
        • Sub-Investigator:
          • Sheila M Badri, MD
        • Sub-Investigator:
          • Blake Max, PharmD
        • Sub-Investigator:
          • Kathleen G Beavis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VircoType HIV-1
Genotypic HIV resistance testing results interpreted by VircoType HIV-1 algorithm
Other: VircoType HIV-1 genotypic interpretation
VircoType HIV-1 genotypic interpretation
Active Comparator: Local Expert review
Local Expert HIV genotypic review, as per Badri, S. et al CID 2003
Other: Local Expert Review of HIV Genotypic resistance testing
Local Expert Review of HIV Genotypic resistance testing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with undetectable viral load 60days after HIV regimen change
Time Frame: 60 days
60 days
Proportion of patients with undetectable viral load 180days after HIV regimen change
Time Frame: 180 days
180 days
CD4 Cell count change in each arm at 60 and 180 days
Time Frame: 60 and 180 days
60 and 180 days
Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days
Time Frame: 180 and 360 days
180 and 360 days
Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed
Time Frame: 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruth M. Rothstein CORE Center

Collaborators

Virco

Investigators

  • Principal Investigator: David E Barker, MD, Ruth M. Rothstein CORE Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2010

Last Update Submitted That Met QC Criteria

January 25, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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