Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00262717




Registration number
NCT00262717
Ethics application status
Date submitted
6/12/2005
Date registered
7/12/2005
Date last updated
9/06/2006

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
Secondary ID [1] 0 0
ACTR012605000781640
Secondary ID [2] 0 0
TVRP9901
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - HIV drug resistance tests based upon genotype testing

Treatment: Devices: HIV drug resistance tests based upon genotype testing
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen
Timepoint [1] 0 0

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 consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2001
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)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Interchange General Practice - Canberra
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Sydney Sexual Health Clinic - Sydney
Recruitment hospital [4] 0 0
AIDS Research Initiative - Sydney
Recruitment hospital [5] 0 0
Albion Street Centre - Sydney
Recruitment hospital [6] 0 0
Holdsworth House General Practice - Sydney
Recruitment hospital [7] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [8] 0 0
Taylor Square Private Clinic - Sydney
Recruitment hospital [9] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [10] 0 0
Livingston Road Sexual Health - Sydney
Recruitment hospital [11] 0 0
QLD Health - AIDS Medical Unit - Brisbane
Recruitment hospital [12] 0 0
Cairns Base Hospital - Cairns
Recruitment hospital [13] 0 0
Gold Coast Sexual Health Clinic - Miami
Recruitment hospital [14] 0 0
Care and Prevention Programme - Adelaide
Recruitment hospital [15] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [16] 0 0
Melbourne Sexual Health Centre - Melbourne
Recruitment hospital [17] 0 0
Prahran Market Clinic - Melbourne
Recruitment hospital [18] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [19] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2031 - Sydney
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment postcode(s) [7] 0 0
4002 - Brisbane
Recruitment postcode(s) [8] 0 0
4870 - Cairns
Recruitment postcode(s) [9] 0 0
4220 - Miami
Recruitment postcode(s) [10] 0 0
- Adelaide
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
3053 - Melbourne
Recruitment postcode(s) [13] 0 0
3141 - Melbourne
Recruitment postcode(s) [14] 0 0
6160 - Fremantle
Recruitment postcode(s) [15] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Abbott
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Boehringer Ingelheim
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
GlaxoSmithKline
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Bristol-Myers Squibb
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/Industry
Name [5] 0 0
Merck Sharp & Dohme LLC
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Commercial sector/Industry
Name [6] 0 0
Roche Pharma AG
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/Industry
Name [7] 0 0
Virco
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Commercial sector/Industry
Name [8] 0 0
Diagnostic Technology
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Commercial sector/Industry
Name [9] 0 0
Perkin Elmer Inc.
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/ct2/show/NCT00262717
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sean Emery, PhD
Address 0 0
The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00262717