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Can Resistance Enhance Selection of Treatment? (CREST)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00262717
Enrollment
338
Registered
2005-12-07
Start date
2001-03-01
Completion date
2006-07-31
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV drug resistance testing, Treatment Experienced

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.

Interventions

DIAGNOSTIC_TESTBlood test: genotype testing

Sponsors

Abbott
CollaboratorINDUSTRY
Boehringer Ingelheim
CollaboratorINDUSTRY
GlaxoSmithKline
CollaboratorINDUSTRY
Bristol-Myers Squibb
CollaboratorINDUSTRY
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Roche Pharma AG
CollaboratorINDUSTRY
Virco
CollaboratorINDUSTRY
Diagnostic Technology
CollaboratorINDUSTRY
Perkin Elmer Inc.
CollaboratorINDUSTRY
Kirby Institute
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.at 48 weeks follow-up

Secondary

MeasureTime frame
Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimenat 48 weeks

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026