BRANCHBURG, NJ--Roche Diagnostic Systems Inc.'s Amplicor H.I.V.-1
monitor test for use in determining viral load in individuals
infected with HIV has received FDA approval for marketing. The
test uses polymerase chain reaction (PCR) technology to measure
HIV genetic material in the blood.
In laboratory studies, the Amplicor test was able in some cases
to detect as few as 400 copies of HIV DNA in a blood sample and
could regularly detect 800 or more copies.
Two clinical trials of Amplicor were conducted in patients with
advanced HIV infection who had received no antiviral treatment
or treatment for less than 16 weeks. The results showed that high
viral load before anti-HIV therapy, or large increases in viral
load after treatment, correlated with increased risk of disease
progression to full-blown AIDS.