HIV InfectionNCT00262717
Can Resistance Enhance Selection of Treatment? (CREST)
A study testing Blood test: genotype testing in people with HIV Infection, run by Kirby Institute at 19 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Blood test: genotype testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 19 sitesAustralia
- Study dates
- 1 Mar 2001to 31 Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected patients taking combination antiretroviral therapy, with plasma HIV RNA> 2000copies/mL, who were willing to change ARVs and who provided informed consent.
Who cannot join
- Patients who were ARV naïve, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Australia19 sites
Care and Prevention Programme
Adelaide, South Australia
QLD Health - AIDS Medical Unit
Brisbane, Queensland, 4002
Cairns Base Hospital
Cairns, Queensland, 4870
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Interchange General Practice
Canberra, Australian Capital Territory
Fremantle Hospital
Fremantle, Western Australia, 6160
Alfred Hospital
Melbourne, Victoria, 3004
Melbourne Sexual Health Centre
Melbourne, Victoria, 3053
Prahran Market Clinic
Melbourne, Victoria, 3141
Gold Coast Sexual Health Clinic
Miami, Queensland, 4220
Royal Perth Hospital
Perth, Western Australia, 6000
Sydney Sexual Health Clinic
Sydney, New South Wales, 2000
AIDS Research Initiative
Sydney, New South Wales, 2010
Albion Street Centre
Sydney, New South Wales, 2010
Holdsworth House General Practice
Sydney, New South Wales, 2010
St. Vincent's Hospital
Sydney, New South Wales, 2010
Taylor Square Private Clinic
Sydney, New South Wales, 2010
Prince of Wales Hospital
Sydney, New South Wales, 2031
Livingston Road Sexual Health
Sydney, New South Wales
About this study
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
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.
- Conditions
- HIV Infection
- Being tested
- Blood test: genotype testing
- Keywords
- HIV drug resistance testing, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test: genotype testingDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Group A: subjects assign to receive a GENOTYPE | Experimental | randomised prior to the selection of their new cART regimen Receives: Diagnostic Test: Blood test: genotype testing |
| Group B: subjects assign to receive a VIRTUAL PHENOTYPE | Experimental | randomised prior to the selection of their new cART regimen Receives: Diagnostic Test: Blood test: genotype testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
Measured: at 48 weeks follow-up
Secondary outcomes (1)
Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen
Measured: at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study start1 Mar 2001
- Primary completion30 Jan 2006
- Study completion31 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Abbott, Boehringer Ingelheim, GlaxoSmithKline, Bristol-Myers Squibb, Merck Sharp & Dohme LLC, Roche Pharma AG, Virco, Diagnostic Technology, Perkin Elmer Inc.
- Responsible party
- Sponsor
- Investigators
- Sean Emery, PhD, Study chair, The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262717
- Sponsor's protocol ID
- TVRP9901
- Other IDs
- ACTR012605000781640
- Status last verified
- Jun 2025
- First submitted
- 6 Dec 2005
- Last updated
- 26 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00262717
- Acronym / sponsor ID
- TVRP9901
- Conditions
- HIV Infection
- Keywords
- HIV drug resistance testing, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Abbott, Boehringer Ingelheim, GlaxoSmithKline, Bristol-Myers Squibb, Merck Sharp & Dohme LLC, Roche Pharma AG, Virco, Diagnostic Technology, Perkin Elmer Inc.
- Study start
- 1 Mar 2001 (actual)
- Primary completion
- 30 Jan 2006 (actual)
- Study completion
- 31 Jul 2006 (actual)
- First posted
- 7 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: subjects assign to receive a GENOTYPE | Experimental | Diagnostic Test: Blood test: genotype testingrandomised prior to the selection of their new cART regimen |
| Group B: subjects assign to receive a VIRTUAL PHENOTYPE | Experimental | Diagnostic Test: Blood test: genotype testingrandomised prior to the selection of their new cART regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV infected patients taking combination antiretroviral therapy, with plasma HIV RNA> 2000copies/mL, who were willing to change ARVs and who provided informed consent.
Key exclusion criteria (1 listed)
- Patients who were ARV naïve, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test: genotype testing | Diagnostic test | Group A: subjects assign to receive a GENOTYPE, Group B: subjects assign to receive a VIRTUAL PHENOTYPE |
Primary outcome
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
Time frame: at 48 weeks follow-up
1 secondary outcome
Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen
Time frame: at 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Emery, PhD study chair
The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test: genotype testing in people with HIV Infection, run by Kirby Institute at 19 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks. (time frame: at 48 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.