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Can Resistance Enhance Selection of Treatment? (CREST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00262717
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : June 9, 2006
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Infection Device: HIV drug resistance tests based upon genotype testing Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : March 2001
Estimated Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262717

Australia, Australian Capital Territory
Interchange General Practice
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Sydney Sexual Health Clinic
Sydney, New South Wales, Australia, 2000
AIDS Research Initiative
Sydney, New South Wales, Australia, 2010
Albion Street Centre
Sydney, New South Wales, Australia, 2010
Holdsworth House General Practice
Sydney, New South Wales, Australia, 2010
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Taylor Square Private Clinic
Sydney, New South Wales, Australia, 2010
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Livingston Road Sexual Health
Sydney, New South Wales, Australia
Australia, Queensland
QLD Health - AIDS Medical Unit
Brisbane, Queensland, Australia, 4002
Cairns Base Hospital
Cairns, Queensland, Australia, 4870
Gold Coast Sexual Health Clinic
Miami, Queensland, Australia, 4220
Australia, South Australia
Care and Prevention Programme
Adelaide, South Australia, Australia
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Melbourne Sexual Health Centre
Melbourne, Victoria, Australia, 3053
Prahran Market Clinic
Melbourne, Victoria, Australia, 3141
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Kirby Institute
Boehringer Ingelheim
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Roche Pharma AG
Diagnostic Technology
Perkin Elmer Inc.
Study Chair: Sean Emery, PhD The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales
More Information

ClinicalTrials.gov Identifier: NCT00262717     History of Changes
Other Study ID Numbers: TVRP9901
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: June 9, 2006
Last Verified: June 2006

Keywords provided by Kirby Institute:
HIV drug resistance testing
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases