AEGiS-FDA: FDA Advisory Committee to Discuss Various AIDS Treatments Food and Drug AdministrationImportant note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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FDA Advisory Committee to Discuss Various AIDS Treatments

Food and Drug Administration, U.S. Department of Health and Human Services - February 2, 1996
Ivy Fleischer Kupec; (301) 443-3285


The Food and Drug Administration will convene a Feb. 28- March 1 meeting of its Antiviral Drugs Advisory Committee and other outside experts to review marketing applications for two protease inhibitor drugs to treat HIV infection and to discuss recent studies of the clinical effectiveness of nucleoside analogue drugs used in combination to delay the complications of HIV infection. Additionally, on March 1st, FDA will convene its Endocrinologic and Metabolic Drugs Advisory Committee to review a marketing application to treat AIDS-related wasting.

On Wednesday, Feb. 28, the committee will discuss recent studies of nucleoside analogues, AZT, ddI and ddC, used to treat HIV infection, including the AIDS Clinical Trial Group (ACTG) Study 175, the Delta study, CPCRA 007 and other relevant studies.

This session will be held at Holiday Inn-Gaithersburg Grand Ballroom, Two Montgomery Village Ave.

On Thursday, Feb. 29, the committee will review data on the safety and effectiveness of ritonavir, the protease inhibitor which Abbott Laboratories manufactures in both liquid and capsules to treat HIV infection. This session also will be held at Holiday Inn-Gaithersburg.

On Friday, March 1, the committee will deliberate on the safety and activity data for indinavir, Merck & Co.'s protease inhibitor. This session will be held at the Holiday Inn- Gaithersburg.

Also on Friday, March 1, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and outside experts will meet to discuss Serono's growth hormone, somatropin, for AIDS-related wasting at the Holiday Inn-Silver Spring Plaza Ballroom, 8777 Georgia Ave.

All sessions will allow for public comments around the midday and are planned to run 8:30 a.m.- 5 p.m., with one exception. The session on somatropin begins at 8 a.m.

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SOURCE: Food and Drug Administration (FDA).

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