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Nerve Growth Factor: Major Trial Canceled, Revived




 

AIDS TREATMENT NEWS Issue #221, April 21, 1995

HIV-associated sensory neuropathy (peripheral neuropathy), a condition resulting from degeneration of nerves caused by HIV infection or by some treatments for HIV, results in pain and disability in up to 30 percent of people with advanced HIV infection; it is the most common neurological complication in AIDS. Several treatments for this condition are now being tested; all but one, however, provide at most symptomatic relief. Recombinant human nerve growth factor is the only treatment now to be tested which might be able to reverse the nerve damage caused by HIV; animal studies have shown that it also completely prevents the nerve damage caused by toxic effects of certain cancer chemotherapy drugs.

A major government-sponsored study of nerve growth factor for treating HIV-related neuropathy has been in development for three years by the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, and by the U.S. National Institute of Neurological Disorders and Stroke. This study will randomly assign 180 volunteers at half a dozen U.S. university medical centers to receive low- dose nerve growth factor (0.1 microgram per kilogram twice per week), high-dose nerve growth factor (0.3 microgram per kilogram on the same schedule), or placebo. The treatment will last for 18 weeks, with a 28-day followup period after treatment is complete; during this time the volunteers will complete daily pain assessments, and in addition have neurological measurements to monitor large and small nerve fiber dysfunction. During the study, pain will be managed by symptomatic treatments. Volunteers will be stratified by history of ddI, ddC, or d4T use, so that effect of the treatment on HIV-associated and treatment-associated neuropathy can be assessed separately.

But in January 1995, Genentech, Inc. of South San Francisco, which holds a patent for this use of recombinant human nerve growth factor, informed the government researchers that it would not provide the drug for the study. Although drug supply is not an issue, and almost all of the financial cost of the study was to be paid by the ACTG, Genentech decided "to focus our personnel, manufacturing, and financial resources on those projects which we feel have the highest likelihood for yielding the most rapid determination of efficacy and safety for each biologic agent currently in development." Genentech planned only to continue a separate trial of nerve growth factor, as a treatment for diabetic neuropathy -- which would constitute a much larger market for the product than HIV neuropathy would, although at least some experts think that the treatment is at least as likely to work for HIV neuropathy as for diabetic neuropathy. And even if the diabetes trial was successful, cancellation of the HIV study would have delayed the availability of the drug for HIV patients for about two years.

After major protests by experts and community organizations alike in early 1995 -- including a national media campaign and a "fax zap" every day of the week of March 27 to top Genentech officials, coordinated by ACT UP/Golden Gate -- Genentech reinstated its earlier agreement to provide drug for the ACTG study; this trial, known as ACTG 291, is now expected to go forward. Activists are still concerned about other Genentech issues, including the recent denial of gamma interferon to the U.S. National Institutes of Health for ACTG 289, a trial of persons co-infected with HIV and tuberculosis. In the past, the company has not had any policy on compassionate use or any form of pre-approval "expanded access" to experimental drugs; but recent negotiations on this issue with breast cancer activists -- concerned about women who need the experimental drug HER/2-neu -- have gone well, and the company is now developing such a policy.

Comment These events show the power of community action which combines two essential elements. First, there was a very strong case, totally supported by the research and medical as well as patient communities, and with no visible opposition anywhere. And second, there was a clear willingness and ability to quickly make the case into a high-profile public issue.

A month ago this writer was skeptical that this dispute could be won; we did not see that the AIDS community had any leverage over Genentech. But the leverage was that no company wants this kind of case raised against it.



 


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Information in this article was accurate in April 21, 1995. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.