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

December 6, 2005
June 8, 2006
March 2001
Not Provided
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
Same as current
Complete list of historical versions of study NCT00262717 on ClinicalTrials.gov Archive Site
Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen
Same as current
Not Provided
Not Provided
 
Can Resistance Enhance Selection of Treatment? (CREST)
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
HIV Infection
Device: HIV drug resistance tests based upon genotype testing
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
August 2002
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00262717
TVRP9901, ACTR012605000781640
Not Provided
Not Provided
Kirby Institute
  • Abbott
  • Boehringer Ingelheim
  • GlaxoSmithKline
  • Bristol-Myers Squibb
  • Merck Sharp & Dohme Corp.
  • Roche Pharma AG
  • Virco
  • 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
Kirby Institute
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP