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Executive Summary

NIH CLINICAL TESTING OF FOUR AIDS ANTIVIRAL AGENTS is planned for fiscal 1986, but more drugs could be tested if additional funds are forthcoming, Acting Assistant Secretary for Health James Mason stated at a Sept. 26 Senate Appropriations HHS subcmte. hearing. The administration's fiscal 1986 request of $126 mil. for HHS activities on Acquired Immune Deficiency Syndrome (AIDS), including $71 mil. for the Natl. Institutes of Health, contemplates the clinical testing of four antivirals, Mason said. The four agents are: Foscarnet (phosphonoformate); HPA 23; Virazole (ribavirin), and Suramin. According to an NIH fact sheet on AIDS therapies, other AIDS antivirals approved for testing under NDs are Ansamycin and Burroughs-Wellcome A509U (Compound S). Immune modulators approved for AIDS clinicals are alpha and gamma interferon; IMREG 1; Interleukin-2; and Isoprinosine. Approved experimental AIDS combination therapies are IL-2 plus Suramin plus bone marrow transplantation, and IL-2 plus Suramin plus alpha interferon. NIH noted that INDs for the treatment of AIDS-related opportunistic infections have been approved for DFMO; Fansidar; DHPG; spiramycin; clofazimine; and rifampin. NDAs also have been approved to market Pentamidine and trimethoprimsulfamethoxazole for AIDS opportunistic infections. Mason stated at the Senate hearing that HHS has asked the administration for an additional $70 mil. in fiscal 1986 for AIDS-related activities. The new request would raise HHS' AIDS budget to $196 mil. which is close to the $189.6 m mil. recommended Sept. 26 by the House Appropriations Cmte. The Senate Appropriations subcmte. also recently approved $129 mil. for HHS AIDS activities in fiscal 1986 Subcmte. Chairman Weicker (R-Conn.) stated at the hearing that he would amend his appropriation recommendation if additional funds are needed. FDA Commissioner Frank Young testified that he has pledged a "zero-time IND" goal for AIDS drugs. "We are prepared to review expeditiously all investigational and marketing applications for products for AIDS, AIDS-related complex and opportunistic infections," he said. Under its fast-track approach, FDA gave investigational approval to two AIDS drugs -- Isoprinosine and HPA 23 -- "in less than a week," Young stated.

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