Ambitious Clinical Trial Stirs Debate

Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Ambitious Clinical Trial Stirs Debate

Science (09/24/99) Vol. 285, No. 5436, P. 2039
Cohen, Jon

The National Institute of Allergy and Infectious Diseases (NIAID) will fund a massive trial of an AIDS treatment during the next five years. The $43 million study has been thoroughly reviewed and rejected once previously, and many researchers still believe its results will not be helpful in developing HIV treatment. NIAID director Anthony Fauci holds a patent on the treatment, which proposes to use genetically engineered interleukin-2 (IL-2) to boost the CD4 levels of HIV-infected individuals. To avoid any conflict of interest, an ad hoc "study section" of peers was convened by the National Cancer Institute, instead of NIAID. The so-called Esprit trial hopes to determine whether an increase in CD4 cells creates longer, healthier lives for HIV patients. Participants in the study will be HIV-infected people who are fairly healthy with at least 300 CD4 cells per millimeter of blood. Critics of the study point out that IL-2 is quite expensive, costing at least $5,000 for three cycles of treatment.

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