The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis
in AIDS patients with nitazoxanide.
Patients take nitazoxanide daily for 8 weeks with a dose
escalation after the first 4 weeks. Patients return to the hospital
for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up.
Nitazoxanide therapy is discontinued in patients showing a complete clinical and
parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing
a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These
patients undergo a physical examination including stool analysis for Cryptosporidium parvum
oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide
therapy. Patients who do not show a complete clinical and parasitologic response
(therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide
therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of
Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a CD4 cell count of 50 cells/mm3 or less.
- Have evidence of cryptosporidium infection in their stool sample within 10 days of
- Have watery stools at least three times a day at least 5 days a week for 21 days
prior to enrollment.
- Are able to take medications by mouth.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Agree to use an effective method of birth control (such as condoms) during the study.
Patients will not be eligible if they:
- Have certain diseases or infections of the intestines.
- Have ever taken nitazoxanide.
- Have taken certain experimental drugs within 14 days of enrollment.
- Will need to take certain other medications during the study such as paromomycin,
azithromycin, and clarithromycin.
- Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting
one during the study.
- Are pregnant or breast-feeding.