Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
The Bay Area Reporter - June 5, 1998
Mike Donnelly, ACT UP/Golden Gate Writers Pool
On May 6, 1998, the Antiviral Drug Advisory Committee of the FDA voted not to recommend approval of the antiparasitic drug Cryptaz(tm) (nitazoxnide, formerly known as NTZ(tm)) licensed in the U.S. by Unimed, the best hope of a treatment for crypto. The FDA must make a decision on the recommendation by June 15, 1998, but approval seems unlikely.
Drug trials
The placebo-controlled study of NTZ from the AIDS Clinical Trails Group (ACTG 336) accrued only 10 of 60 needed participants in one year and the study was closed on May 15, 1998 due to low enrollment. This is both good news and bad news. The good news is that there are fewer cases of crypto than in the past. The bad news is crypto is still here. The symptoms of diarrhea, cramps, nausea, and low-grade fever can be life-threatening to people with compromised immune systems.
Unimed's application to the FDA was based on three open label studies conducted by the company. The drug was studied in doses of 500-2000 mg. The Advisory Committee did not find the information from these studies convincing. The company has stated that if they don't get a conditional approval from the FDA they will not continue to develop the drug for treatment of crypto.
Best advice
The parasite is carried in animal and human feces so people should avoid contact as much as possible. The United States Public Health Guidelines state "Modes of transmission include contact with infected adults and diaper-aged children, contact with infected animals, drinking contaminated water, and contact with contaminated water during recreational activities."
Dr. Carolyn Peterson, at San Francisco General Hospital, says, "The best way to prevent crypto is a point of use water filter. Don't travel without your own filter and don't trust bottled water in foreign countries." She cites the crypto outbreak in Las Vegas, which has state-of-the-art water treatment system, as proof that filtration doesn't always work. To be effective against crypto, the filters must remove particles 1mm in diameter. Also remember that chlorine in swimming pools does not kill crypto.
How do I get treatment?
In all three of the recent cases of crypto at San Francisco General, the patients have not been on Highly Active Antiretroviral Therapy (HAART) (a.k.a. triple-drug therapy and cocktail therapy). Dr. Judith Aberg, a treating physician at San Francisco General, has instituted HAART for two of the crypto infections with no other treatment. One patient, who had a high viral load and low T-cells, says he is feeling better, but hasn't been in for follow-up.
Dr. Peterson states "People who have crypto should be on HAART". She explains that in Peru adults who have measurable crypto in their stools don't get sick, but children who have the same levels do exhibit symptoms. "It appears adult immune systems are fighting the crypto, and children's immune systems aren't as developed."
(When asked about NTZ she says, "Do I think it works? No, I don't. But I wouldn't want to deny anyone access.")
Dr. Carl Fichtenbaum, Assistant Professor at Washington University in St. Louis and head of ACTG 336, states, "I have two recent patients with crypto. Primary therapy for my crypto patients is HAART and watching their nutrition like a hawk."
On the subject of NTZ he says, "I don't know the correct dose. We don't see any toxicity at 3000 mg. I don't think the company knows the correct dose." He goes on to say, "I think NTZ is a so-so drug. The data presented [at the FDA Advisory hearing] shows it works about as well as paramomycin."
Where to get NTZ
Unimed, the company that holds an exclusive license for the U.S., is continuing their compassionate use program, until they hear about approval from the FDA. They can be contacted at 1-800-864-6330. Your physician may apply for compassionate use. "The paperwork can be completed and faxed to us and the physician can get emergency IRB approval," assures Dr. Bob Dudley of Unimed. "The drug can be shipped within a week."
NTZ is being sold through the PWA Health Group, a buyer's club in New York. It currently has a supply and can be contacted at (212) 255-0520. Healing Alternative Foundation (HAF) in San Francisco also carries the NTZ and can be contacted at (415) 626-4053.
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