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AIDS Treatment News
FDA Advisory Committees Meet January 26 on Salk HIV-1 Immunogen

January 6, 1995
AIDS TREATMENT NEWS Issue #214, January 6, 1995

On January 26, two advisory committees of the FDA (the Antiviral Drugs Advisory Committee, which considers most AIDS drugs, and the Vaccines and Related Biological Products Advisory Committee) will meet jointly to consider future clinical trials of the HIV-1 Immunogen, a potential AIDS treatment developed by Jonas Salk, M.D.

The Immune Response Corporation (IRC), of Carlsbad, California, has already conducted a number of clinical trials of the immunogen; 235 patients have received it in clinical trials since 1987, with no drug-related serious adverse events and no patients dropping out of trials due to adverse events. Now IRC plans to run three larger trials, involving a total of almost 5,000 volunteers. These trials, which will last from two to four years, will test the treatment in three groups of patients: those with T-helper count under 300, those with 300-549, and those with 550 and above.

The HIV Immunogen is made with killed HIV, much like killed- virus vaccines for other diseases. The current and proposed trials are not testing it as a preventive vaccine, however, but as a treatment for existing HIV infection. Previous trials have shown evidence of improvement in various immunological and other blood tests; however, they have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new studies are intended to determine that, and also to validate the use of blood-test "markers" of disease progression for studying an immune-based treatment such as the immunogen.

Volunteers in the previous trials have shown much interest in continuing their treatment. Those in California have long been able to do so (due to California approval by the state's Food and Drug Branch), but those in other states have not. The FDA has already approved a continuation protocol, which applies to volunteers in all states, but supplies of the Immunogen have been limited due to manufacturing issues which are currently being overcome.

The joint meeting will be held at the Holiday Inn, Bethesda, Maryland, Versailles Ballrooms I through III, starting at 8 a.m. The first session, from 8:00 a.m. to 10:45 a.m. on January 26, will be closed to the public, apparently to deal with manufacturing issues; the rest of the meeting is expected to be open to the public, with a public hearing from 10:45 to 11:30; persons wishing to speak should make arrangements in advance, if possible before January 19. [Note: the advisory committee meeting will continue on January 27, to deal with other matters.] For more information, contact Judy Rappaport, Salk Immunogen Working Group of ACT UP/Philadelphia, 215/972-1454.

www.aegis.org