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HIGHLIGHTS FROM IDSA
97 The SUN Study:
M61005
Dr. Michael Sension (North Broward Hospital District, Ft.
Lauderdale, FL) presented a poster that confirmed the safety and efficacy of the regimen
of FORTOVASE + AZT + 3TC. This open-label, non-comparative study was designed to evaluate
this combination using HIV RNA, CD4, and CD8 counts as markers over a 24-week period.
Forty subjects with HIV RNA
> 10,000 copies/ml, CD4 cells counts > 100 cells/mm3, and no previous
antiretroviral therapy were enrolled.
Preliminary data of the 30 subjects who have results for
week 12 showed a mean viral load drop of 2.74 log10. Seventy-seven percent of
the subjects at week 12 were below the standard level of detection (400 copies/ml) and 23
percent were below the 20 copies/ml threshold of detection using the ultrasensitive assay.
These subjects also experienced a mean increase of 143 CD4 cells/mm3 at week
12. Adverse events on this regimen were classified as mild, with gastrointestinal
complaints being the most common.
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