The Bay Area Reporter - January 23, 1996
Stephen LeBlanc, ACT UP/Golden Gate Writers Pool

The drug's U.S. distributor, Unimed Pharmaceuticals, Inc., has stated that NTZ will soon available under a compassionate use program to people with AIDS and has pledged to make the drug immediately available to treat very serious cases of cryptosporidium, provided individual FDA approval for the emergency treatment can be obtained.

NTZ is now in a Phase I/Phase II study with one site at Cornell Medical Center in New York City. An additional site is being planned for Kaiser Permanente in San Francisco, though that site may be very limited in number of patients. (Unimed may be reached at 1-800-864-6330.)

NTZ was first synthesized in 1976 and has been shown to have antimicrobial activity against a wide range of intestinal human parasites including protozoan, helminthic (worms), and bacterial pathogens. More that 1,000 people world-wide have taken the drug for a variety of indications, and the drug appears to be well-tolerated in humans. It is reported that in an open-label trial in Mali, 15 patients with advanced AIDS and cryptosporidial enteritis were given NTZ at 500 mg orally twice a day for seven days.

Two-thirds of these patients had clearance of crypto based on two negative stool examinations. Similar promising results were reported in a Mexican study with the same dose for 14 days, with six of seven patients having a reduction of diarrhea symptoms and all seven testing negative for crypto after treatment. These are the best results claimed to date for any drug for treatment of cryptosporidium in people with AIDS. Preliminary reports from the ongoing Cornell study, using various dosages from 500 to 2000 mg per day, suggest diarrhea symptom reduction in most patients, but have not shown as promising results in clearance of cryptosporidium.

Only minor side-effects have thus far been seen in the few patients who have been treated, with about ten percent of patients reporting symptoms such as abdominal pain, diarrhea, nausea, headache, or dizziness.

In one anecdotal report, East Bay resident and physician Mike Alcalay stated that he contracted cryptosporidium last March, resulting in severe diarrhea and weight-loss from 170 to 138 pounds. Alcalay learned of NTZ through his doctor early last summer, after being on TPN intravenous feeding and trying and failing other treatments including paromomycin (Humatin) and azithromycin (zithromaz). Alcalay, who had CD4 counts of around 50 at the time he came down with crypto, flew to Mexico to enroll in a study of the drug conducted through the World Health Organization.

Alcalay stated that two to three weeks after beginning drug treatment, his diarrhea resolved and his weight has since gone up to 156, and added, "It saved my life."

Alcalay reported he has taken the drug for four months at a dose of 1500 mg twice a day (somewhat higher than dosages currently being studied in the United States). The only side effect he reported was nausea that lessened when the drug was taken with food. Alcalay said that although he has had some negative crypto stool readings since taking NTZ, his diarrhea symptoms occasionally return and his stool then tests positive for cryptosporidium. "Although the drug has not been a cure for me," Alcalay continued, "I feel it has brought the disease under control."

Dr. Robert Dudley of Unimed reports that the company is moving forward to complete studies necessary to obtain FDA approval of the drug. At present, the FDA has not approved a wide-scale compassionate use protocol, but has approved emergency individual treatment protocols in a few cases. Dudley stated that Unimed was very sensitive to people in dire situations and that he had worked with Dr. David Senechek in San Francisco to provide NTZ on an emergency basis to one patient.

According to Dudley, the company has a very large supply of the drug and anticipates no supply problems. Dudley pledged that Unimed would provide drug quickly to patients in critical situations, providing the FDA agreed. NTZ is reportedly very cheap to manufacture, and Unimed is supplying the drug free of charge, pending FDA approval.

Unimed had no comment as to the drug's eventual costs if FDA approval is obtained. Despite the positive reports, people with AIDS should be aware that the drug has not been conclusively shown to be beneficial in fighting cryptosporidia.

Cryptosporidium is a single-celled protozoan that commonly infects the intestinal tract and less commonly infects other organs. It can cause mild to severe diarrhea and other symptoms. According to the U.S. Centers for Disease Control, people with largely intact immune systems generally clear the parasite in a few weeks without treatment, but people with less than about 180 CD4 cells almost never do. In those people, the infection and symptoms can become chronic and life-threatening.

Cryptosporidium is spread through drinking tap water and through any oral/anal contact either during sex, use of public swimming pools, or care giving. During sex, crypto can easily be spread from the anus to a hand, then to another body part, then to the mouth. Cryptosporidium has been found in levels associated with disease in San Francisco and many other municipal water supplies.

To avoid contacting crypto from drinking water, only drink bottled water or water that has been brought to a rolling boil for at least a minute. To avoid contracting crypto during sex, avoid both direct and indirect oral/anal contact. t

An open label compassionate use protocol of NTZ is expected to begin at San Francisco General Hospital in about six weeks. Interested persons should contact Dr. Lisa Gooze at (415) 476-4082, extensiuon 84024. People who wish to use NTZ and have difficulty obtaining it from Unimed should contact ACT UP/Golden Gate at (415) 252-9200.

ACTion UPdate:

Speak Out About Kaiser Care for People With AIDS

The Health, Public Safety, and Environment Committee of the San Francisco Board of Supervisors continues hearing testimony regarding the care provided at Kaiser Permanente and other city-contracted health insurers to people with HIV/AIDS next Thursday, February 1, at 1 p.m. The hearing will be at the Temporary City Hall (the War Memorial Building at Van Ness and McAllister), Board of Supervisors Conference Room, 4th Floor. One issue being brought before the committee is whether the city should continue its contract with Kaiser. People with HIV or their loved ones who have received care at Kaiser with stories to tell are urged to attend or provide testimony in writing. For more information call ACT UP/Golden Gate at (415) 252-9200 or Supervisor Tom Ammiano's office at (415) 554-5144.
960123
BR960103

Always watch for outdated information. This article first appeared in 1996. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1996. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .