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THE EMERGENCE of new HIV/AIDS drugs is a double-edged sword for clinicians, pharmaceutical companies, and researchers who design and implement clinical trials.
More treatment options abound, but physicians have little guidance in how to determine the best drug combinations. And while experts argue about whether clinical decisions should be based on study results using surrogate markers, such as viral load, or clinical end points of progression to AIDS or death, they tend to agree that combination therapy renders obsolete clinical trial designs that stack one agent up against AZT (zidovudine) monotherapy.
"It's the best of times and the worst of times right now in this epidemic," remarked Kenneth H. Mayer, MD, director of the AIDS program at Brown University Medical School, Providence, RI, during a recent conference on clinical AIDS research. It was sponsored by Boston, Mass—based Public Responsibility in Medicine and Research, an organization devoted to ethics in research.
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