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Can Resistance Enhance Selection of Treatment? (CREST)

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
HIV drug resistance tests based upon genotype testing
Sponsored by
Kirby Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Infection focused on measuring HIV drug resistance testing, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Interchange General Practice
  • Royal Prince Alfred Hospital
  • Sydney Sexual Health Clinic
  • AIDS Research Initiative
  • Albion Street Centre
  • Holdsworth House General Practice
  • St. Vincent's Hospital
  • Taylor Square Private Clinic
  • Prince of Wales Hospital
  • Livingston Road Sexual Health
  • QLD Health - AIDS Medical Unit
  • Cairns Base Hospital
  • Gold Coast Sexual Health Clinic
  • Care and Prevention Programme
  • Alfred Hospital
  • Melbourne Sexual Health Centre
  • Prahran Market Clinic
  • Fremantle Hospital
  • Royal Perth Hospital

Outcomes

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

Full Information

First Posted
December 6, 2005
Last Updated
June 8, 2006
Sponsor
Kirby Institute
Collaborators
Abbott, Boehringer Ingelheim, GlaxoSmithKline, Bristol-Myers Squibb, Merck Sharp & Dohme LLC, Roche Pharma AG, Virco, Diagnostic Technology, Perkin Elmer Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00262717
Brief Title
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

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kirby Institute
Collaborators
Abbott, Boehringer Ingelheim, GlaxoSmithKline, Bristol-Myers Squibb, Merck Sharp & Dohme LLC, Roche Pharma AG, Virco, Diagnostic Technology, Perkin Elmer Inc.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV drug resistance testing, Treatment Experienced

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
HIV drug resistance tests based upon genotype testing
Primary Outcome Measure Information:
Title
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
Secondary Outcome Measure Information:
Title
Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Emery, PhD
Organizational Affiliation
The National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales
Official's Role
Study Chair
Facility Information:
Facility Name
Interchange General Practice
City
Canberra
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Sydney Sexual Health Clinic
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
AIDS Research Initiative
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Albion Street Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House General Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St. Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Taylor Square Private Clinic
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Prince of Wales Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Livingston Road Sexual Health
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
QLD Health - AIDS Medical Unit
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4002
Country
Australia
Facility Name
Cairns Base Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Gold Coast Sexual Health Clinic
City
Miami
State/Province
Queensland
ZIP/Postal Code
4220
Country
Australia
Facility Name
Care and Prevention Programme
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Melbourne Sexual Health Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Prahran Market Clinic
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3141
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia

12. IPD Sharing Statement

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Can Resistance Enhance Selection of Treatment? (CREST)

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