Can Resistance Enhance Selection of Treatment? (CREST)

Kirby Institute

Status: Completed

Conditions: HIV Infection

Treatments: Diagnostic Test: Blood test: genotype testing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00262717

TVRP9901

ACTR012605000781640

Details and patient eligibility

About

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.

Enrollment: 338 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 2 patient groups

Group A: subjects assign to receive a GENOTYPE

Experimental group

Description:

randomised prior to the selection of their new cART regimen

Treatment:

Diagnostic Test: Blood test: genotype testing

Group B: subjects assign to receive a VIRTUAL PHENOTYPE

Experimental group

Description:

randomised prior to the selection of their new cART regimen

Treatment:

Diagnostic Test: Blood test: genotype testing