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Trial registered on ANZCTR


Registration number
ACTRN12605000781640
Ethics application status
Approved
Date submitted
6/12/2005
Date registered
7/12/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can resistance enhance selection of treatment? (CREST)
Scientific 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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV infection 937 0
Condition category
Condition code
Infection 1007 1007 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will compare two different assay platforms for assessment of HIV drug resistance used to assist in the selection of antiretroviral regimens. The two platforms are genotypic testing (GT) and Virtual Phenotype testing (VP). Subjects will be randomly allocated to receive the results from one platform alone on one occasion at entry to the study. Patients will be followed for a period of one year for measures of plasma HIV RNA, CD4+ T lymphocyte count and changes to antiretroviral therapy. We hypothesise that one test will be significantly superior to the other.
Intervention code [1] 788 0
Diagnosis / Prognosis
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1346 0
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA
Timepoint [1] 1346 0
At 48 weeks
Secondary outcome [1] 2395 0
Proportion of patients with undetectable plasma HIV RNA
Timepoint [1] 2395 0
At 48 weeks.
Secondary outcome [2] 2396 0
Changes in CD4+ cell count
Timepoint [2] 2396 0
Up to 48 weeks
Secondary outcome [3] 2397 0
Use of resistance test result in selecting new ART regimen.
Timepoint [3] 2397 0
At baseline.

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who were ARV naive, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A single centrally located randomisation code was prepared using computer algorithms. Randomisation was stratified by clinical site and by number of prior antiretroviral regimens (< or > 4 previous)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1104 0
Commercial sector/Industry
Name [1] 1104 0
Abbott Australasia
Address [1] 1104 0
Country [1] 1104 0
Australia
Funding source category [2] 1105 0
Commercial sector/Industry
Name [2] 1105 0
Boehringer-Ingleheim
Address [2] 1105 0
Country [2] 1105 0
Germany
Funding source category [3] 1106 0
Commercial sector/Industry
Name [3] 1106 0
GlaxoSmithKline
Address [3] 1106 0
Country [3] 1106 0
United Kingdom
Funding source category [4] 1107 0
Commercial sector/Industry
Name [4] 1107 0
Bristol-Myers Squibb
Address [4] 1107 0
Country [4] 1107 0
United States of America
Funding source category [5] 1108 0
Commercial sector/Industry
Name [5] 1108 0
Merck Sharpe and Dohme
Address [5] 1108 0
Country [5] 1108 0
Funding source category [6] 1109 0
Commercial sector/Industry
Name [6] 1109 0
Roche
Address [6] 1109 0
Country [6] 1109 0
Funding source category [7] 1110 0
Commercial sector/Industry
Name [7] 1110 0
Virco
Address [7] 1110 0
Country [7] 1110 0
Funding source category [8] 1111 0
Commercial sector/Industry
Name [8] 1111 0
Diagnostic Technology
Address [8] 1111 0
Country [8] 1111 0
Funding source category [9] 1112 0
Commercial sector/Industry
Name [9] 1112 0
Perkin Elmer Biosystems
Address [9] 1112 0
Country [9] 1112 0
Primary sponsor type
Government body
Name
National Centre in HIV Epidemiology and Clinical Research
Address
Country
Australia
Secondary sponsor category [1] 971 0
University
Name [1] 971 0
The University of New South Wales
Address [1] 971 0
Country [1] 971 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2402 0
Melbourne Sexual Health.
Ethics committee address [1] 2402 0
Ethics committee country [1] 2402 0
Australia
Date submitted for ethics approval [1] 2402 0
Approval date [1] 2402 0
Ethics approval number [1] 2402 0
Ethics committee name [2] 2403 0
Taylor Square Private Clinic
Ethics committee address [2] 2403 0
Sydney
Ethics committee country [2] 2403 0
Australia
Date submitted for ethics approval [2] 2403 0
Approval date [2] 2403 0
Ethics approval number [2] 2403 0
Ethics committee name [3] 2404 0
Prahran Market Clinic
Ethics committee address [3] 2404 0
Melbourne
Ethics committee country [3] 2404 0
Australia
Date submitted for ethics approval [3] 2404 0
Approval date [3] 2404 0
Ethics approval number [3] 2404 0
Ethics committee name [4] 2405 0
Gold Coast Sexual Health.
Ethics committee address [4] 2405 0
Ethics committee country [4] 2405 0
Australia
Date submitted for ethics approval [4] 2405 0
Approval date [4] 2405 0
Ethics approval number [4] 2405 0
Ethics committee name [5] 2406 0
Queensland Health
Ethics committee address [5] 2406 0
Brisbane
Ethics committee country [5] 2406 0
Australia
Date submitted for ethics approval [5] 2406 0
Approval date [5] 2406 0
Ethics approval number [5] 2406 0
Ethics committee name [6] 2407 0
Cairns Base Hospital.
Ethics committee address [6] 2407 0
Ethics committee country [6] 2407 0
Australia
Date submitted for ethics approval [6] 2407 0
Approval date [6] 2407 0
Ethics approval number [6] 2407 0
Ethics committee name [7] 2408 0
Care and Prevention Programme
Ethics committee address [7] 2408 0
Adelaide
Ethics committee country [7] 2408 0
Australia
Date submitted for ethics approval [7] 2408 0
Approval date [7] 2408 0
Ethics approval number [7] 2408 0
Ethics committee name [8] 2409 0
Holdsworth House GP
Ethics committee address [8] 2409 0
Sydney
Ethics committee country [8] 2409 0
Australia
Date submitted for ethics approval [8] 2409 0
Approval date [8] 2409 0
Ethics approval number [8] 2409 0
Ethics committee name [9] 2410 0
Fremantle Hospital.
Ethics committee address [9] 2410 0
Ethics committee country [9] 2410 0
Australia
Date submitted for ethics approval [9] 2410 0
Approval date [9] 2410 0
Ethics approval number [9] 2410 0
Ethics committee name [10] 2411 0
Sydney Sexual Health Clinic.
Ethics committee address [10] 2411 0
Ethics committee country [10] 2411 0
Australia
Date submitted for ethics approval [10] 2411 0
Approval date [10] 2411 0
Ethics approval number [10] 2411 0
Ethics committee name [11] 2412 0
Interchange GP
Ethics committee address [11] 2412 0
Canberra
Ethics committee country [11] 2412 0
Australia
Date submitted for ethics approval [11] 2412 0
Approval date [11] 2412 0
Ethics approval number [11] 2412 0
Ethics committee name [12] 2413 0
Alfred Hospital
Ethics committee address [12] 2413 0
Melbourne
Ethics committee country [12] 2413 0
Australia
Date submitted for ethics approval [12] 2413 0
Approval date [12] 2413 0
Ethics approval number [12] 2413 0
Ethics committee name [13] 2414 0
Livingston Rd Sexual Health
Ethics committee address [13] 2414 0
Sydney
Ethics committee country [13] 2414 0
Australia
Date submitted for ethics approval [13] 2414 0
Approval date [13] 2414 0
Ethics approval number [13] 2414 0
Ethics committee name [14] 2415 0
Royal Prince Alfred Hospital
Ethics committee address [14] 2415 0
Sydney
Ethics committee country [14] 2415 0
Australia
Date submitted for ethics approval [14] 2415 0
Approval date [14] 2415 0
Ethics approval number [14] 2415 0
Ethics committee name [15] 2416 0
St Vincents Hospital
Ethics committee address [15] 2416 0
Sydney
Ethics committee country [15] 2416 0
Australia
Date submitted for ethics approval [15] 2416 0
Approval date [15] 2416 0
Ethics approval number [15] 2416 0
Ethics committee name [16] 2417 0
Prince of Wales Hospital
Ethics committee address [16] 2417 0
Sydney
Ethics committee country [16] 2417 0
Australia
Date submitted for ethics approval [16] 2417 0
Approval date [16] 2417 0
Ethics approval number [16] 2417 0
Ethics committee name [17] 2418 0
Albion Street Centre
Ethics committee address [17] 2418 0
Sydney
Ethics committee country [17] 2418 0
Australia
Date submitted for ethics approval [17] 2418 0
Approval date [17] 2418 0
Ethics approval number [17] 2418 0
Ethics committee name [18] 2419 0
AIDS Research Initiative
Ethics committee address [18] 2419 0
Sydney
Ethics committee country [18] 2419 0
Australia
Date submitted for ethics approval [18] 2419 0
Approval date [18] 2419 0
Ethics approval number [18] 2419 0
Ethics committee name [19] 2420 0
Royal Perth Hospital.
Ethics committee address [19] 2420 0
Ethics committee country [19] 2420 0
Australia
Date submitted for ethics approval [19] 2420 0
Approval date [19] 2420 0
Ethics approval number [19] 2420 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35137 0
Address 35137 0
Country 35137 0
Phone 35137 0
Fax 35137 0
Email 35137 0
Contact person for public queries
Name 9977 0
Associate Professor Sean Emery BSc(Hons), PhD
Address 9977 0
The National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 9977 0
Australia
Phone 9977 0
+61 2 93850900
Fax 9977 0
+61 2 93850910
Email 9977 0
semery@nchecr.unsw.edu.au
Contact person for scientific queries
Name 905 0
Associate Professor Sean Emery BSc(Hons), PhD
Address 905 0
The National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 905 0
Australia
Phone 905 0
+61 2 93850900
Fax 905 0
+61 2 93850910
Email 905 0
semery@nchecr.unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary