Can Resistance Enhance Selection of Treatment? (CREST)

June 8, 2006 updated by: Kirby Institute

A Randomised Comparator Study to Assess the Relative Efficacy of Genotypic Versus Virtual Phenotypic Resistance Tests in Treatment Experienced Patients With HIV Infection for Whom a Change in Therapy is Indicated

To compare two commercially available platforms for assessment of HIV drug resistance to determine which provides superior virological results.

We hypothesise that one test will be significantly superior to the other.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

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

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia
        • Interchange General Practice
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2010
        • St. Vincent's Hospital
      • Sydney, New South Wales, Australia, 2010
        • AIDS Research Initiative
      • Sydney, New South Wales, Australia, 2010
        • Holdsworth House General Practice
      • Sydney, New South Wales, Australia, 2010
        • Taylor Square Private Clinic
      • Sydney, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Sydney, New South Wales, Australia, 2010
        • Albion Street Centre
      • Sydney, New South Wales, Australia, 2000
        • Sydney Sexual Health Clinic
      • Sydney, New South Wales, Australia
        • Livingston Road Sexual Health
    • Queensland
      • Brisbane, Queensland, Australia, 4002
        • QLD Health - AIDS Medical Unit
      • Cairns, Queensland, Australia, 4870
        • Cairns Base Hospital
      • Miami, Queensland, Australia, 4220
        • Gold Coast Sexual Health Clinic
    • South Australia
      • Adelaide, South Australia, Australia
        • Care and Prevention Programme
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Melbourne, Victoria, Australia, 3053
        • Melbourne Sexual Health Centre
      • Melbourne, Victoria, Australia, 3141
        • Prahran Market Clinic
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV infected patients taking combination antiretroviral therapy, with plasma HIV RNA> 2000copies/mL, who were willing to change ARVs and who provided informed consent.

Exclusion Criteria:

  • Patients who were ARV naïve, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.

Secondary Outcome Measures

Outcome Measure
Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen

Collaborators and Investigators

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

Sponsor

Kirby Institute

Collaborators

Bristol-Myers Squibb
GlaxoSmithKline
Merck Sharp & Dohme LLC
Roche Pharma AG
Boehringer Ingelheim
Abbott
Virco
Diagnostic Technology
Perkin Elmer Inc.

Investigators

  • Study Chair: Sean Emery, PhD, The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales

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, 2001

Study Completion

August 1, 2002

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Estimate)

June 9, 2006

Last Update Submitted That Met QC Criteria

June 8, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVRP9901
  • ACTR012605000781640

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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