Clinical trial NCT00262717: Can Resistance Enhance Selection of Treatment? (CREST)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Keywords: HIV drug resistance testing
Treatment Experienced
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: Abbott
name: Boehringer Ingelheim
name: GlaxoSmithKline
name: Bristol-Myers Squibb
name: Merck Sharp & Dohme LLC
name: Roche Pharma AG
name: Virco
name: Diagnostic Technology
name: Perkin Elmer Inc.
First posted: 2005-12-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
Secondary outcomes:
measure: Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Interchange General Practice
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Sexual Health Clinic
state: New South Wales
city: Sydney
country: Australia
facility: AIDS Research Initiative
state: New South Wales
city: Sydney
country: Australia
facility: Albion Street Centre
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House General Practice
state: New South Wales
city: Sydney
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Taylor Square Private Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Livingston Road Sexual Health
state: New South Wales
city: Brisbane
country: Australia
facility: QLD Health - AIDS Medical Unit
state: Queensland
city: Cairns
country: Australia
facility: Cairns Base Hospital
state: Queensland
city: Miami
country: Australia
facility: Gold Coast Sexual Health Clinic
state: Queensland
city: Adelaide
country: Australia
facility: Care and Prevention Programme
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Melbourne Sexual Health Centre
state: Victoria
city: Melbourne
country: Australia
facility: Prahran Market Clinic
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales
name: Sean Emery, PhD
role: STUDY_CHAIR
References: