A Study of Nitazoxanide in Patients With AIDS and Diarrhea Caused by Cryptosporidium
National Institute of Allergy and Infectious Diseases (NIAID)
To determine the frequency of complete, marked, and partial clinical responses in patients
with cryptosporidiosis treated with 6 weeks of NTZ versus 21 days of placebo. To determine
the safety of NTZ in subjects with cryptosporidiosis.
There is no proven therapy for cryptosporidiosis in persons with AIDS. Nitazoxanide appears
to be a good candidate drug for further evaluation because of its effectiveness in
preclinical models, the data from early clinical trials and its safety profile. Cooperation
between clinical researchers and basic scientists in clinical trials of agents for HIV
infection and its complications is a high priority for the ACTG, the NIAID, and the NIH.
Thus, it is important to design a clinical trial of NTZ that includes cooperation with basic
A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients
with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ
following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe,
contributing substantially to morbidity, mortality, and health care costs in this
population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial
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