A Study of Nitazoxanide in Patients With AIDS and Diarrhea Caused by Cryptosporidium
Completed
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 2
1969-12-31
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
scientists.
A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis
Unknown status
Romark Laboratories L.C.
N/A
1969-12-31
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).
A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
Completed
Unimed Pharmaceuticals
Phase 1
1995-10-01
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 these
patients.
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 infection.
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