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NCT00262717 Clinical Trial

Can Resistance Enhance Selection of Treatment? (CREST)

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00262717
Other study ID # TVRP9901
Secondary ID ACTR012605000781
Status Completed
Phase Phase 4
First received December 6, 2005
Last updated June 8, 2006
Start date March 2001
Est. completion date August 2002

Study information
Verified date June 2006
Source Kirby Institute
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date August 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• HIV drug resistance tests based upon genotype testing

Locations
Country Name City State
Australia Care and Prevention Programme Adelaide South Australia
Australia QLD Health - AIDS Medical Unit Brisbane Queensland
Australia Cairns Base Hospital Cairns Queensland
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Interchange General Practice Canberra Australian Capital Territory
Australia Fremantle Hospital Fremantle Western Australia
Australia Alfred Hospital Melbourne Victoria
Australia Melbourne Sexual Health Centre Melbourne Victoria
Australia Prahran Market Clinic Melbourne Victoria
Australia Gold Coast Sexual Health Clinic Miami Queensland
Australia Royal Perth Hospital Perth Western Australia
Australia AIDS Research Initiative Sydney New South Wales
Australia Albion Street Centre Sydney New South Wales
Australia Holdsworth House General Practice Sydney New South Wales
Australia Livingston Road Sexual Health Sydney New South Wales
Australia Prince of Wales Hospital Sydney New South Wales
Australia St. Vincent's Hospital Sydney New South Wales
Australia Sydney Sexual Health Clinic Sydney New South Wales
Australia Taylor Square Private Clinic Sydney New South Wales

Sponsors (10)
Lead Sponsor Collaborator
Kirby Institute Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Diagnostic Technology, GlaxoSmithKline, Merck Sharp & Dohme Corp., Perkin Elmer Inc., Roche Pharma AG, Virco

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
Secondary Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen
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