WASHINGTON -- At the request of the Food and Drug Administration, the drug company that produces the experimental AIDS drug DDC has established two programs to fill the void created by the lack of DDC on the underground market, FDA officials said yesterday.
Recently, the agency discovered the DDC being sold by illegal "buyer's clubs" varied considerably in strength from the doses thought to be most effective and urged the clubs to discontinue selling it -- which they are believed to have done.
FDA officials, who have exercised a hands-off attitude toward the illegal clubs -- because they appreciate the desperation of those seeking the therapies -- believed that some action was needed to replenish the supply for patients unable to obtain the drug, which is being developed by Hoffmann-La Roche Inc., of Nutley, N.J.
The new programs will allow DDC to be given together with AZT, another antiviral AIDS drug, a combination which has been shown in limited studies to have a more beneficial effect on the immune system than AZT alone.
The drug company already has a program of expanded access for the drug, but only for patients who take DDC alone because they cannot medically tolerate AZT.
In recent years, the FDA has relaxed its rules regarding the use of experimental drugs for acquired immune deficiency syndrome drugs to allow individuals greater access to them while they are still being studied.
"We appreciate that the buyer's clubs worked with us to maintain the good quality of the drugs they were selling and we applaud Hoffmann-La Roche for coming in to fulfill an important need," FDA Commissioner David A. Kessler said yesterday.
Both programs will remain under a large-scale research umbrella, that is, information gleaned from them will be used by federal health officials to evaluate the efficacy of the drug. The company already has applied for marketing approval.
The first program, slated to begin within two weeks, will provide DDC to two groups of individuals infected with the human immunodeficiency virus who wish to take the combination therapy.
These include those who already have experienced symptoms of disease and have CD4 cell counts of 300 or fewer, and those with CD4 counts of 200 or fewer who have not yet exhibited symptoms.
CD4 cells, also known as T helper cells, are the primary target of HIV. In healthy individuals, a normal CD4 count ranges between 800 and 1,200. As these critical immune system cells are destroyed, the body becomes prone to a range of life-threatening infections and other serious conditions.
DDC and AZT together have been shown, in small studies, to increase the level of CD4 cells for higher levels and for longer periods of time than AZT alone.
The second program, a so-called "large simple trial," will involve an estimated 10,000 to 15,000 healthier HIV-infected individuals -- those with CD4 counts of up to 500.
The program will use combination AZT-DDC therapy but will compare different doses of DDC -- a high dose vs. a low dose.