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

Primary Purpose

HIV-1, HIV Infections

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

VircoType HIV-1 genotypic interpretation

Local Expert Review of HIV Genotypic resistance testing

About this trial

This is an interventional diagnostic trial for HIV-1 focused on measuring HIV-1, HIV, HIV Genotypic testing, resistance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Ruth M. Rothstein CORE CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VircoType HIV-1

Local Expert review

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of patients with viral load <1000 60days after HIV regimen change

Proportion of patients with viral load <1000 180 days after HIV regimen change

Secondary Outcome Measures

Proportion of patients with undetectable viral load 60days after HIV regimen change

Proportion of patients with undetectable viral load 180days after HIV regimen change

CD4 Cell count change in each arm at 60 and 180 days

Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days

Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed

Full Information

NCT ID

NCT00840762

First Posted

February 9, 2009

Last Updated

January 25, 2010

Sponsor

Ruth M. Rothstein CORE Center

Collaborators

Virco

1. Study Identification

Unique Protocol Identification Number

NCT00840762

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

March 2009 (undefined)

Primary Completion Date

February 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Ruth M. Rothstein CORE Center

Collaborators

Virco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-1, HIV Infections

Keywords

HIV-1, HIV, HIV Genotypic testing, resistance

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

756 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VircoType HIV-1

Arm Type

Experimental

Arm Description

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

Arm Title

Local Expert review

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

VircoType HIV-1 genotypic interpretation

Intervention Description

VircoType HIV-1 genotypic interpretation

Intervention Type

Other

Intervention Name(s)

Local Expert Review of HIV Genotypic resistance testing

Intervention Description

Local Expert Review of HIV Genotypic resistance testing

Primary Outcome Measure Information:

Title

Proportion of patients with viral load <1000 60days after HIV regimen change

Time Frame

60 days

Title

Proportion of patients with viral load <1000 180 days after HIV regimen change

Time Frame

180 days

Secondary Outcome Measure Information:

Title

Proportion of patients with undetectable viral load 60days after HIV regimen change

Time Frame

60 days

Title

Proportion of patients with undetectable viral load 180days after HIV regimen change

Time Frame

180 days

Title

CD4 Cell count change in each arm at 60 and 180 days

Time Frame

60 and 180 days

Title

Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days

Time Frame

180 and 360 days

Title

Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed

Time Frame

180 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David E Barker, MD

Phone

312-572-4503

dbarker@corecenter.org

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Kroc, MPH

Phone

312-572-4765

kkroc@corecenter.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David E Barker, MD

Organizational Affiliation

Ruth M. Rothstein CORE Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ruth M. Rothstein CORE Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David E Barker, MD

First Name & Middle Initial & Last Name & Degree

Harold A Kessler, MD

First Name & Middle Initial & Last Name & Degree

Sheila M Badri, MD

First Name & Middle Initial & Last Name & Degree

Blake Max, PharmD

First Name & Middle Initial & Last Name & Degree

Kathleen G Beavis, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

12942405

Citation

Badri SM, Adeyemi OM, Max BE, Zagorski BM, Barker DE. How does expert advice impact genotypic resistance testing in clinical practice? Clin Infect Dis. 2003 Sep 1;37(5):708-13. doi: 10.1086/377266. Epub 2003 Aug 15.

Results Reference

background

Links:

URL

http://www.corecenter.org/

Description

The CORE Center

URL

http://www.cchil.org/index.html

Description

Cook County Hospital Department of Medicine

URL

http://www.uic.edu/pharmacy/about_the_college/index.php

Description

UIC College of Pharmacy

Learn more about this trial

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

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