Can Resistance Enhance Selection of Treatment? (CREST)

NCT ID: NCT00262717

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-01

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: subjects assign to receive a GENOTYPE

randomised prior to the selection of their new cART regimen

Group Type EXPERIMENTAL

Blood test: genotype testing

Intervention Type DIAGNOSTIC_TEST

Group B: subjects assign to receive a VIRTUAL PHENOTYPE

randomised prior to the selection of their new cART regimen

Group Type EXPERIMENTAL

Blood test: genotype testing

Intervention Type DIAGNOSTIC_TEST

Interventions

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Blood test: genotype testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Virco

INDUSTRY

Sponsor Role collaborator

Diagnostic Technology

INDUSTRY

Sponsor Role collaborator

Perkin Elmer Inc.

INDUSTRY

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Emery, PhD

Role: STUDY_CHAIR

The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales

Locations

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Interchange General Practice

Canberra, Australian Capital Territory, Australia

Site Status

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

Sydney Sexual Health Clinic

Sydney, New South Wales, Australia

Site Status

AIDS Research Initiative

Sydney, New South Wales, Australia

Site Status

Albion Street Centre

Sydney, New South Wales, Australia

Site Status

Holdsworth House General Practice

Sydney, New South Wales, Australia

Site Status

St. Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

Taylor Square Private Clinic

Sydney, New South Wales, Australia

Site Status

Prince of Wales Hospital

Sydney, New South Wales, Australia

Site Status

Livingston Road Sexual Health

Sydney, New South Wales, Australia

Site Status

QLD Health - AIDS Medical Unit

Brisbane, Queensland, Australia

Site Status

Cairns Base Hospital

Cairns, Queensland, Australia

Site Status

Gold Coast Sexual Health Clinic

Miami, Queensland, Australia

Site Status

Care and Prevention Programme

Adelaide, South Australia, Australia

Site Status

Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Melbourne Sexual Health Centre

Melbourne, Victoria, Australia

Site Status

Prahran Market Clinic

Melbourne, Victoria, Australia

Site Status

Fremantle Hospital

Fremantle, Western Australia, Australia

Site Status

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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ACTR012605000781640

Identifier Type: -

Identifier Source: secondary_id

TVRP9901

Identifier Type: -

Identifier Source: org_study_id

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