Can Resistance Enhance Selection of Treatment? (CREST)

This study has been completed.
Sponsor:
Collaborators:
Abbott
Boehringer Ingelheim
GlaxoSmithKline
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Roche Pharma AG
Virco
Diagnostic Technology
Perkin Elmer Inc.
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00262717
First received: December 6, 2005
Last updated: June 8, 2006
Last verified: June 2006
  Purpose

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 Intervention Phase
HIV Infection
Device: HIV drug resistance tests based upon genotype testing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

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

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

Estimated Enrollment: 300
Study Start Date: March 2001
Estimated Study Completion Date: August 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262717

Locations
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
Livingston Road Sexual Health
Sydney, New South Wales, Australia
Holdsworth House General Practice
Sydney, New South Wales, Australia, 2010
Sydney Sexual Health Clinic
Sydney, New South Wales, Australia, 2000
AIDS Research Initiative
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
Albion Street Centre
Sydney, New South Wales, Australia, 2010
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
Abbott
Boehringer Ingelheim
GlaxoSmithKline
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Roche Pharma AG
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00262717     History of Changes
Other Study ID Numbers: TVRP9901, ACTR012605000781640
Study First Received: December 6, 2005
Last Updated: June 8, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
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

ClinicalTrials.gov processed this record on September 30, 2014