Nelfinavir: Agouron Announces Expanded Access for Children, a Major New Trial, and Enlarged Expanded Access for Adults

The protease inhibitor nelfinavir (VIRACEPT(R)) is not yet approved for marketing, but is available to some patients through an expanded access program. Nelfinavir may have fewer side effects than the currently approved protease inhibitors.

On January 6 the drug's developer, Agouron Pharmaceuticals, Inc. of La Jolla, California, announced that it will make nelfinavir available "without charge to any HIV-infected child [ages 2-13 years] until the drug is approved for marketing in the United States." Safety trials have been run in children, and are expected to be presented next week at the 4th Conference on Retroviruses and Opportunistic Infections. Agouron has developed an oral powder formulation for children, while it was developing the tablets for adults.

So far no protease inhibitor has been available for children, outside of small trials, because dosage and safety studies had not been completed.

Physicians, health-care professionals, and parents interested in the VIRACEPT Pediatric Expanded Access Program can call the VIRACEPT Expanded Access Program Hotline, 800/621-7111, Monday through Friday from 8:00 a.m. to 6:00 p.m. Eastern time.

* On January 6 Agouron announced a large clinical trail to compare nelfinavir plus nucleoside analogs (AZT, 3TC, ddI, ddC, d4T) vs. ritonavir (Norvir(R)) plus nucleoside analogs. 1300 persons with CD4 count under 100 will be randomly assigned to one or the other treatment. This trial will be run by the CPCRA, an AIDS research program of the U.S. National Institute of Allergy and Infectious Diseases, and the Canadian HIV Trials Network. It seems to be well regarded by treatment activists, because both treatment arms are appropriate therapy, with neither designed to likely be weaker than the other.

For information on enrolling in this trial, call the AIDS Clinical Trials Information Service, 800/TRIALS-A.

* On January 8 Agouron relaxed the entry criteria for its expanded access program for adults (age 13 and older). "People will now qualify for the VIRACEPT Expanded Access Program if they are unable to take indinavir (Crixivan(R)) and/or ritonavir due to intolerance or prior failure and who have had CD4+ T-cell counts of less than or equal to 100 cells/mm3 during any past medical examination." Previously it was necessary to be unable to use all three approved protease inhibitors, and to have a CD4 count under 50. For information on this program, call the VIRACEPT Expanded Access Program Hotline, 800/621-7111, Monday through Friday from 8:00 a.m. to 6:00 p.m. Eastern time.

* On December 23 Agouron announced that it had applied to the FDA for approval to market nelfinavir in the U.S. The company is applying under the FDA's accelerated approval regulations for both the adult tablets and the pediatric powder formulations. These regulations allow approval based on blood-test results such as viral load, but require large human trials later to prove clinical benefit.