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Executive Summary

NIAID INCREASING AIDS OPPORTUNISTIC DISEASE PROTOCOLS BY 30%-40% over the next year, National Institute of Allergy & Infectious Diseases Director Anthony Fauci, MD, told a May 14 Washington, D.C. "town forum" on AIDS sponsored by the Institute for Advanced Studies in Immunology and Aging. The increase represents 12 new protocols on opportunistic infections. Over the last 12 months, the number of NIAID studies on opportunistic diseases increased from 10% of all AIDS protocols to 20%, Fauci said. The number of participants in opportunistic studies increased from 600 to about 2,000 during this period. NIAID also plans to add six protocols on HIV infection over the next year. The opportunistic protocols are likely to be more expensive and more complicated than viral studies in which an asymptomatic patient can be treated with AZT, Fauci commented. "As soon as the hospital finds out that you want to do a protocol study on [a patient with an opportunistic infection], many hospitals will immediately withdraw third-party payment," Fauci observed. "So all of a sudden the protocol has to pay for it. Instead of costing $500 to $1,000 [per] patient, it's going to cost $15,000 to $20,000 depending on how sick the person is. This is something that needs to be addressed; that's beyond our control." NIAID also plans to increase the participation of intraveneous drug users in AIDS clinical trials to 20%, about equalling the percentage of drug users in the overall AIDS population, Fauci told the public forum. Currently, drug users represent about 10% of the total clinical trial population. Fauci was one of four clinical experts participating on the panel. Robert Gallo, MD, chief of the Laboratory of Tumor Cell Biology at the National Cancer Institute, was questioned about the "confidentiality agreement" between NCI and an unnamed Japanese pharmaceutical company to develop a drug to treat Kaposi's sarcoma. "We contacted this company and met with them," Gallo responded. "They had never collaborated with the United States Government before...only within pharmaceutical companies within Europe and Japan. They wanted a confidentiality agreement to get more of an idea of the drug" under investigation, he said, adding that NCI has completed "only the first stage of the study." George Washington University researcher Allen Goldstein, PhD, said the first phase of testing the AIDS vaccine HGP-30 in HIV-negative individuals is nearing completion. Results are expected to be presented at the International AIDS conference in San Francisco in June.

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