The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients
suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium).
Patients receive oral nitazoxanide daily for 14 days, after which those with complete
clinical and parasitologic response discontinue treatment. Non-responders and partial
responders may continue therapy for an additional 14 days at the discretion of the
physician. Non-responders who show signs of improvement or who have partial response after
28 days and those who relapse following complete response may continue therapy for an
additional month, up to 60 days total. [AS PER AMENDMENT 10/30/96: Patients receive a daily
treatment for 4 weeks, with subsequent dose escalation in the absence of drug-related
toxicity. Patients who exhibit complete response after 2 months may continue at a
maintenance dose. Patients enrolled after October 15, 1996 are randomized to 1 of 2 doses,
with subsequent escalations made in the absence of toxicity. Complete responders may
continue therapy at a maintenance dose and duration determined by the investigator.
Non-responders after 6 months of therapy have treatment discontinued.] [AS PER AMENDMENT
8/5/97: All patients are evaluated at Weeks 1, 2, 4, and monthly thereafter.] [AS PER
AMENDMENT 8/17/99: New patients start therapy on a different dosage of nitazoxanide. Those
who do not respond after 4 weeks of therapy will escalate to a higher dosage. Patients who
show a complete response at 2 consecutive visits (2 weeks apart) discontinue nitazoxanide
therapy and go to follow-up.] [AS PER AMENDMENT 2/3/00: The Week 1 clinical evaluation is
deleted from the study procedures.]
Patients may be eligible for this study if they:
- Are 3 to 65 years old (need consent of parent or guardian if under 18).
- Have AIDS.
- Have a CD4 count less than or equal to 200 cells/mm3. (Note: Patients with a CD4
count greater than 200 cells/mm3 but who have had cryptosporidiosis for at least 4
weeks may be eligible for this study.)
- Test positive for the parasite Cryptosporidium and have severe diarrhea (at least 4
bowel movements per day) for at least 2 weeks.
- Have received treatment for cryptosporidiosis but have become reinfected after
- Agree to practice abstinence or use effective methods of birth control (such as a
condom) before and during the study.
Patients will not be eligible for this study if they:
- Are pregnant.
- Are infected with certain other parasites.
- Have a history of certain intestinal diseases.
- Have received certain medications.