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OpenTrials
Completed

NCT Number: NCT00262717

Can Resistance Enhance Selection of Treatment? (CREST)

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.

Completed

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interchange General Practice, Canberra, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood test: genotype testing

Diagnostic Test

Primary outcomes

  1. 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

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

    Time frame: at 48 weeks

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • Abbott
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Diagnostic Technology
  • GlaxoSmithKline
  • Merck Sharp & Dohme LLC
  • Perkin Elmer Inc.
  • Roche Pharma AG
  • Virco

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Dec 7, 2005
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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