(ATN) NAC: Important Study Needs Volunteers

(ATN) NAC: Important Study Needs Volunteers

AIDS TREATMENT NEWS #138, November 1, 1991
John S. James

A small but important 15-week study of the experimental HIV treatment N-acetylcysteine (NAC) has been delayed because of lack of volunteers. The reasons few people have volunteered have been (1) this trial was not widely known, although it was listed in some directories; (2) until recently it was only open to residents of the Washington, DC area (since no travel funds were available); and (3) there is some discomfort involved, as the drug is given intravenously for part of the time, and one lumbar puncture is required. On the other hand, NAC is much safer than most experimental drugs, and the trial will give participants the best blood work available anywhere, including repeated plasma viremia tests, at no cost. No hospitalization is required. The entry criteria are easy to meet. Since travel expenses can now be paid, persons from anywhere in the U. S. can volunteer. And it is important for the AIDS community that this study be completed.

The trial is being run by the U. S. National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health campus near Washington, D. C. ; it is sponsored in part by Zambon Corporation of East Rutherford, New Jersey, a subsidiary of the Italian pharmaceutical company which is developing NAC as a potential HIV treatment. A total of 16 volunteers are needed; seven are already in the trial, and three others are waiting to start.

NAC has long been used in Europe as a bronchitis treatment. In the U. S., it is approved for aerosol use in treating bronchial mucous associated with cystic fibrosis and other lung conditions, and also as an antidote for poisoning due to acetaminophen (e.g. Tylenol) overdose. Laboratory studies by several different research groups have built a strong case that the drug should be tested as a treatment for AIDS or HIV; we hope to review these studies in a future issue of AIDS TREATMENT NEWS.

NAC is widely available in buyers' clubs and health-food stores, and is already in wide use as one of the most common "alternative" treatments. But until trials are done we cannot know for sure that it is working, or (if it is) how to use it best. There are anecdotal reports of cases of significant benefit, but there are also people NAC seems not to help. And the theory and laboratory data suggests that in many cases benefit might be long-term, with no way to tell quickly if the treatment is working -- especially for those who are healthy to begin with and have no obvious illness to indicate possible benefit from the drug.

The NIAID trial will not by itself tell if NAC is useful, but it will provide data to improve the design of larger studies, which will soon be ready to begin. This early trial will determine how well the drug is absorbed, and how well it crosses the blood-brain barrier, in persons with AIDS or HIV. It will also test if there is any drug interaction between NAC and AZT, ddC, or ddI. And it will obtain preliminary data on whether NAC reduces viremia, or improves T-helper counts or other measures of immune functioning. Although no surprises are expected, it is good practice to do a small, rapid test like this to to help assure that later studies are optimally designed.

Volunteers must be HIV positive and have T-helper counts less than 500 (there is no lower limit). They can be using AZT, ddI, or ddC (through the expanded-access program), but must not use experimental drugs except ddC during the study; those with T-helper count under 200 should also be on pneumocystis prophylaxis, either by aerosol pentamidine or by oral drugs. They cannot have a serious infection when they begin the study; those with KS are eligible, but must not have received systemic therapy for KS (other than alpha interferon) within two months of starting the NAC study. There are also various medical exclusion conditions, including certain abnormal blood counts and blood- chemistry tests.

Potential volunteers should call Ms. Chris Boenning, RN, MSN, 800/772-5464 ext. 401.

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