Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
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GMHC Treatment Issues; Vol 9, Number 9 - September 1995
Theo Smart
NTZ is a broad spectrum anti-parasitic originally formulated for veterinary use. It was invented by Jean-Franìois Rossignol, Ph.D., the same researcher who discovered albendazole, a drug that has shown activity against microsporidiosis. NTZ has been studied for treating mixed parasitic infections in Egyptian and Colombian adults and children. Over 700 people participated in these trials. The drug appears to be well tolerated -- abdominal pain, nausea and diarrhea are the most common adverse events.
According to Dr. Dudley, unpublished NIH-sponsored test-tube and rodent studies found that NTZ had greater anti- cryptosporidiosis activity than paromomycin (Humatin) at substantially lower doses. The drug also showed anti- cryptosporidia activity in people with late stage AIDS (less than ten CD4 cells) during studies in Mali and Mexico.
The Malian trial participants were infected with other parasites besides Cryptosporidium parvum, and unlike most people with AIDS in the U.S., the Malians were not receiving antiretroviral treatment. Nevertheless, after one week on NTZ (500 mg twice a day), two-thirds of the 24 patients showed clinical improvement and clearance of cryptosporidia.
The Mexican study comprised seven patients treated with 500 mg NTZ twice daily for fourteen days. There were no adverse events, and six of the seven participants' diarrhea resolved, with substantial clearance of the cryptosporidia. Data from these studies are being submitted for publication.
These results sound very promising, but dramatic clinical improvements in cryptosporidiosis have been reported in foreign trials for a number of other drugs, including letrazuril. Those agents never seemed to work when studied in the U.S., though.
As was perhaps the case with the earlier drugs, NTZ's antidiarrheal effect may be due to its activity against other, concurrent parasitic infections, which may have been the primary cause of diarrhea in the people under study. Persons with concurrent intestinal infections will be excluded from the U.S. studies. Unimed anticipates beginning a phase I/II study with Rosemary Soave, M.D., at Cornell Medical School in mid-September.
This dose-ranging study will include four groups of seven patients. Doses will be 500 mg, 1,000 mg, 1,500 mg, or 2,000 mg a day for fourteen days. The study will gather pharmacokinetic and safety data. On days seven and fourteen, patients will be monitored for the drug's effect on diarrhea and clearance of cryptosporidia.
Call 212/746-6320 for more information on this trial.
The company expects the Phase I/II trial to be finished and the data analyzed by December. It plans to move directly into multicenter phase III trials by early next year.
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