Can Resistance Enhance Selection of Treatment? (CREST)
This study has been completed.
Sponsor:
Kirby Institute
Collaborators:
Abbott
Boehringer Ingelheim Pharmaceuticals
GlaxoSmithKline
Bristol-Myers Squibb
Merck
Roche Pharma AG
Virco
Diagnostic Technology
Perkin Elmer Inc.
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00262717
First received: December 6, 2005
Last updated: June 8, 2006
Last verified: June 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Device: HIV drug resistance tests based upon genotype testing |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Kirby Institute:
Primary Outcome Measures:
- The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
Secondary Outcome Measures:
- Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2001 |
| Estimated Study Completion Date: | August 2002 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262717
Locations
| Australia, Australian Capital Territory | |
| Interchange General Practice | |
| Canberra, Australian Capital Territory, Australia | |
| Australia, New South Wales | |
| Royal Prince Alfred Hospital | |
| Camperdown, New South Wales, Australia, 2050 | |
| Albion Street Centre | |
| Sydney, New South Wales, Australia, 2010 | |
| Holdsworth House General Practice | |
| Sydney, New South Wales, Australia, 2010 | |
| Prince of Wales Hospital | |
| Sydney, New South Wales, Australia, 2031 | |
| AIDS Research Initiative | |
| Sydney, New South Wales, Australia, 2010 | |
| St. Vincent's Hospital | |
| Sydney, New South Wales, Australia, 2010 | |
| Taylor Square Private Clinic | |
| Sydney, New South Wales, Australia, 2010 | |
| Sydney Sexual Health Clinic | |
| Sydney, New South Wales, Australia, 2000 | |
| Livingston Road Sexual Health | |
| Sydney, New South Wales, Australia | |
| Australia, Queensland | |
| QLD Health - AIDS Medical Unit | |
| Brisbane, Queensland, Australia, 4002 | |
| Cairns Base Hospital | |
| Cairns, Queensland, Australia, 4870 | |
| Gold Coast Sexual Health Clinic | |
| Miami, Queensland, Australia, 4220 | |
| Australia, South Australia | |
| Care and Prevention Programme | |
| Adelaide, South Australia, Australia | |
| Australia, Victoria | |
| Alfred Hospital | |
| Melbourne, Victoria, Australia, 3004 | |
| Melbourne Sexual Health Centre | |
| Melbourne, Victoria, Australia, 3053 | |
| Prahran Market Clinic | |
| Melbourne, Victoria, Australia, 3141 | |
| Australia, Western Australia | |
| Fremantle Hospital | |
| Fremantle, Western Australia, Australia, 6160 | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
Sponsors and Collaborators
Kirby Institute
Abbott
Boehringer Ingelheim Pharmaceuticals
GlaxoSmithKline
Bristol-Myers Squibb
Merck
Roche Pharma AG
Virco
Diagnostic Technology
Perkin Elmer Inc.
Investigators
| Study Chair: | Sean Emery, PhD | The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00262717 History of Changes |
| Other Study ID Numbers: | TVRP9901, ACTR012605000781640 |
| Study First Received: | December 6, 2005 |
| Last Updated: | June 8, 2006 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Kirby Institute:
|
HIV drug resistance testing Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 17, 2013