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NTZ -- Still Promising but Unimed Walks!

September 1998

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

In early May, an FDA Advisory Committee recommended that the FDA not approve Unimed's NTZ (brand name Cryptaz). The committee asked for more analysis of the data Unimed presented, but when Unimed went to the FDA again in mid-June, the company's application was strongly rejected once again.

The PWA Health Group has been importing NTZ (nitazoxanide) for PWAs with cryptosporidiosis for over two years. Our decision to carry NTZ was based on a numberof factors: the lack of effective treatments for this debilitating, and sometimes fatal, parasitic infection; promising results from small trials in PWAs in Mali and Mexico; the lack of serious side-effects, toxicities or drug interactions; and the refusal of the drug's manufacturer, Unimed, to open large enough clinical trials and an ethical compassionate use program for PWAs who needed access to the drug.

Unimed is now doing virtually nothing; there are no new studies of the drug planned. Certainly, there are fewer cases of cryptosporidiosis and microsporidiosis at present due to combination therapy; this perceived smaller market doesn't encourage drug development for opportunistic infections. Unimed's data were abysmal -- not because NTZ might not be effective, but because the trials were problematic in design, analysis was almost non-existent, and the number of people studied extremely small (228 people, with only 67 meeting the criteria required to figure out whether or not the drug worked). Unimed presented data based on its open-label compassionate use program -- that's all! The bottom line is that none of us know how effective NTZ is in fighting crypto or micro or even the diarrhea caused by these parasites. We don't even know the correct dose if the drug is effective.

The somewhat good news: Unimed's NTZ compassionate use program is still open, at least for the time being. Your doctor has to enroll you and get approval from his or her IRB (Institutional Review Board). You must have documented crypto and be over age 3, but there's no longer any set T-cell criteria. The dosage you'll receive once your doctor has filed the necessary paperwork will be either 1,000 mg or 2,000 mg per day -- the dose isn't up to or your doctor. In other words, you may receive a suboptimal dose. After four weeks, Unimed will adjust your dose upward if you have shown no clinical improvement. Unfortunately, Unimed's ethics have not improved. Call Sandy Faulkner at Unimed: (800) 864-6330 x3032.

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If Unimed closes the compassionate use program and/or conducts no further studies of NTZ, we have useful strategies as a community to demand access. The company has only three approved products. Between marinol for weight loss, maxaquin, used for urinary and respiratory tract infections, and andranol, an anabolic steroid, their market is us! These products can be substituted with other company's products to varying degrees (or, in the case of marinol, with medical marijuana). According to Senior Vice President Robert Dudley, Unimed is exploring other options" for NTZ, "including future work," a vague statement, to say the least, that doesn't bode well for NTZ's future. We have to watch Unimed carefully. If NTZ is studied intelligently, we may have the first effective treatment for crypto. The worst case scenario? Well, we still don't know. Meanwhile, the PWA Health Group continues to import NTZ from Mexico for people who need it.


Back to the September 1998 contents page.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by PWA Health Group. It is a part of the publication Notes From the Underground.
 
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