Can Resistance Enhance Selection of Treatment? (CREST)

• Sponsor: Kirby Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00262717
• Collaborator: Abbott (Industry), Boehringer Ingelheim (Industry), GlaxoSmithKline (Industry), Bristol-Myers Squibb (Industry), Merck Sharp & Dohme LLC (Industry), Roche Pharma AG (Industry), Virco (Industry), Diagnostic Technology (Industry), Perkin Elmer Inc. (Industry)
• Enrollment: 300
• Locations: 19
• Duration (Months): 17
• Patients Per Site: 15.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection	Device: HIV drug resistance tests based upon genotype testing	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2001
• Study Completion Date: Aug 1, 2002

Outcome Measures

Primary Outcome Measures

1. The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks. []

Secondary Outcome Measures

1. Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Interchange General Practice	Canberra	Australian Capital Territory	Australia
2	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
3	Sydney Sexual Health Clinic	Sydney	New South Wales	Australia	2000
4	AIDS Research Initiative	Sydney	New South Wales	Australia	2010
5	Albion Street Centre	Sydney	New South Wales	Australia	2010
6	Holdsworth House General Practice	Sydney	New South Wales	Australia	2010
7	St. Vincent's Hospital	Sydney	New South Wales	Australia	2010
8	Taylor Square Private Clinic	Sydney	New South Wales	Australia	2010
9	Prince of Wales Hospital	Sydney	New South Wales	Australia	2031
10	Livingston Road Sexual Health	Sydney	New South Wales	Australia
11	QLD Health - AIDS Medical Unit	Brisbane	Queensland	Australia	4002
12	Cairns Base Hospital	Cairns	Queensland	Australia	4870
13	Gold Coast Sexual Health Clinic	Miami	Queensland	Australia	4220
14	Care and Prevention Programme	Adelaide	South Australia	Australia
15	Alfred Hospital	Melbourne	Victoria	Australia	3004
16	Melbourne Sexual Health Centre	Melbourne	Victoria	Australia	3053
17	Prahran Market Clinic	Melbourne	Victoria	Australia	3141
18	Fremantle Hospital	Fremantle	Western Australia	Australia	6160
19	Royal Perth Hospital	Perth	Western Australia	Australia	6000

Sponsors and Collaborators

• Kirby Institute
• Abbott
• Boehringer Ingelheim
• GlaxoSmithKline
• Bristol-Myers Squibb
• Merck Sharp & Dohme LLC
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00262717
• Other Study ID Numbers: TVRP9901; ACTR012605000781640
• First Posted: Dec 7, 2005
• Last Update Posted: Jun 9, 2006
• Last Verified: Jun 1, 2006

• Keywords provided by , ,: HIV drug resistance testing; Treatment Experienced
• Additional relevant MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome

Study Results

No Results Posted as of Jun 9, 2006