None listed
Conditions
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
The trial will compare two different assay platforms for assessment of HIV drug resistance used to assist in the selection of antiretroviral regimens. The two platforms are genotypic testing (GT) and Virtual Phenotype testing (VP). Subjects will be randomly allocated to receive the results from one platform alone on one occasion at entry to the study. Patients will be followed for a period of one year for measures of plasma HIV RNA, CD4+ T lymphocyte count and changes to antiretroviral therapy.
The trial will compare two different assay platforms for assessment of HIV drug resistance used to assist in the selection of antiretroviral regimens. The two platforms are genotypic testing (GT) and Virtual Phenotype testing (VP). Subjects will be randomly allocated to receive the results from one platform alone on one occasion at entry to the study. Patients will be followed for a period of one year for measures of plasma HIV RNA, CD4+ T lymphocyte count and changes to antiretroviral therapy. We hypothesise that one test will be significantly superior to the other.
Sponsors
National Centre in HIV Epidemiology and Clinical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 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.
Exclusion criteria
Patients who were ARV naive, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.
Outcome results
None listed