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Prospective
Trials of Drug Resistance Testing
GART
A multicenter, randomized pilot study to determine the short-term
effects of genotypic analysis in management of patients failing
antiretroviral therapy provides additional supportive evidence (20).
In this trial (CPCRA 046, or "GART" [Genotypic Antiretroviral
Resistance Testing]), 153 patients with an increasing plasma HIV-1
RNA level after at least 16 weeks of treatment with a triple-drug
combination regimen were randomized to receive either genotypic
data and expert interpretation or standard clinical management.
At week 12, patients in the genotyping arm had a significantly greater
reduction in plasma HIV-1 RNA from baseline as compared to those
in the control arm. The proportion of patients achieving a plasma
HIV-1 RNA <500 copies/mL was also significantly greater in the
genotyping arm. Within both treatment groups, the virologic response
correlated with the number of active drugs prescribed.
Several caveats
should be kept in mind regarding the GART study:
1) "expert" advice regarding patient management was provided
only to the genotyping group;
2) follow-up to date is limited to 12 weeks;
3) expert advice was ignored by the treating physician in a substantial
proportion of the genotyping patients. Nevertheless, these results
are consistent with the conclusions of Viradapt.
4/15/01
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by HIV and Hepatitis.com. All Rights Reserved
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