HIV-1 Genotyping System in Clinical Trials

A new diagnostic system, now in clinical trials, sequences the strain of HIV-1 virus infecting the patient, providing clinicians with information not provided by existing diagnostic sources such as the patient's history. The system targets protease and reverse transcriptase genes in the HIV-1 virus that spontaneously develop drug-resistant mutations at a rapid rate.

This genotyping system, called ViroSeq, is the product of Applied Biosystems Group (Foster City, CA, USA), a business of Applera Corp. The clinical objectives of the trials are to investigate the impact of secondary mutations upon clinical expert interpretation of expected drug resistance, to determine if clinical expert opinion offers a different interpretation of resistance from that predicted by a rules-based algorithm, and to measure the prevalence of secondary and other mutations in a select population of HIV-1 patients.

"Physicians could in the future be able to prescribe treatment regimens that might be precisely tailored to the type of HIV-1 drug-resistant strain infecting the patient,” said Tony C. Lam, senior manager for regulatory affairs at Applied Biosystems.



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