CLINICAL TRIALS PROFILE FOR NITAZOXANIDE
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All Clinical Trials for NITAZOXANIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00001081 ↗ | 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. |
| NCT00002158 ↗ | 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). |
| NCT00002444 ↗ | 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. |
| NCT00004986 ↗ | Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients | Terminated | Romark Laboratories L.C. | Phase 3 | 2000-02-01 | The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide. |
| NCT00055107 ↗ | Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 1/Phase 2 | 1969-12-31 | Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries. C. parvum infection can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV infected children. The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C. parvum. Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants, children, and adolescents with chronic diarrhea caused by C. parvum infection. |
| NCT00055107 ↗ | Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1/Phase 2 | 1969-12-31 | Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries. C. parvum infection can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV infected children. The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C. parvum. Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants, children, and adolescents with chronic diarrhea caused by C. parvum infection. |
| NCT00130390 ↗ | Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease | Terminated | Romark Laboratories L.C. | Phase 2 | 2005-08-01 | The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's disease in adults. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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