MedPath

Nitazoxanide

Generic Name
Nitazoxanide
Brand Names
Alinia, Busulfex
Drug Type
Small Molecule
Chemical Formula
C12H9N3O5S
CAS Number
55981-09-4
Unique Ingredient Identifier
SOA12P041N
Background

Nitazoxanide belongs to the class of drugs known as thiazolides. Nitazoxanide (NTZ) is a broad-spectrum anti-infective drug that markedly modulates the survival, growth, and proliferation of a range of extracellular and intracellular protozoa, helminths, anaerobic and microaerophilic bacteria, in addition to viruses. This drug is effective in the treatment of gastrointestinal infections including Cryptosporidium parvum or Giardia lamblia in healthy subjects. It is generally well tolerated. Nitazoxanide is a first-line, standard treatment for illness caused by C. parvum or G. lamblia infection in healthy (not immunosuppressed) adults and children and may also be considered in the treatment of illnesses caused by other protozoa or helminths . Recently, this drug has been studied as a broad-spectrum antiviral agent due to its ability to inhibit the replication of several RNA and DNA viruses .

Indication

用于治疗隐孢子虫、贾第鞭毛虫、阿米巴原虫引起的原虫性腹泻。

Associated Conditions
Diarrhea caused by Cryptosporidium parvum, Diarrhea caused by Giardia lamblia

Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects

Phase 2
Completed
Conditions
HIV Infection
Hepatitis C Infection
Interventions
Drug: Pegylated interferon alfa-2a (PEG)
First Posted Date
2009-10-08
Last Posted Date
2021-11-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
68
Registration Number
NCT00991289
Locations
🇺🇸

Stanford AIDS Clinical Trials Unit CRS, Palo Alto, California, United States

🇺🇸

Columbia P&S CRS, New York, New York, United States

🇺🇸

Trillium Health ACTG CRS, Rochester, New York, United States

and more 15 locations

4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
Biological: Peginterferon alfa-2a
First Posted Date
2008-10-01
Last Posted Date
2008-10-01
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
40
Registration Number
NCT00763568
Locations
🇪🇬

Digestive Disease Center, Tanta, Egypt

Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

Not Applicable
Completed
Conditions
Diarrhea
Rotavirus Infection
Interventions
Drug: Probiotic mix preparation
Other: Oral hydration solutions
First Posted Date
2008-05-26
Last Posted Date
2008-05-26
Lead Sponsor
Centro Pediatrico Albina de Patino
Target Recruit Count
75
Registration Number
NCT00683982
Locations
🇧🇴

Centro Pediatrico Albina Patiño, Cochabamba, Bolivia

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
Drug: Placebo
Biological: Peginterferon alfa-2a
First Posted Date
2008-03-18
Last Posted Date
2014-02-10
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
112
Registration Number
NCT00637923
Locations
🇺🇸

Florida Center for Gastroenterology, Largo, Florida, United States

🇺🇸

New York Presbyterian-Weill Medical College of Cornell University, New York, New York, United States

🇺🇸

Palo Alto VA Healthcare System, Palo Alto, California, United States

and more 7 locations

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
Drug: Placebo
Biological: Peginterferon alfa-2a
First Posted Date
2007-07-03
Last Posted Date
2014-05-08
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
64
Registration Number
NCT00495391
Locations
🇺🇸

VA Palo Alto Healthcare System, Palo Alto, California, United States

🇺🇸

McGuire VA Medical Center, Richmond, Virginia, United States

🇺🇸

Nashville Medical Research Institute, Nashville, Tennessee, United States

and more 7 locations

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
Biological: Peginterferon alfa-2a
First Posted Date
2007-01-12
Last Posted Date
2008-09-25
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
121
Registration Number
NCT00421434
Locations
🇪🇬

Department of Tropical Medicine & Infectious Diseases, Alexandria University, Alexandria, Egypt

🇪🇬

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine, Tanta, Egypt

Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

Phase 2
Completed
Conditions
Chronic Hepatitis C
First Posted Date
2007-01-05
Last Posted Date
2007-01-05
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
50
Registration Number
NCT00418639
Locations
🇪🇬

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine, Tanta, Egypt

🇪🇬

Cairo Liver & GIT Center, Cairo, Egypt

🇪🇬

Department of Tropical Medicine & Infectious Diseases, Alexandria University, Alexandria, Egypt

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Phase 2
Completed
Conditions
Clostridium Difficile
First Posted Date
2007-01-04
Last Posted Date
2007-01-04
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
114
Registration Number
NCT00417872
Locations
🇺🇸

WellStar Infectious Diseases, Marietta, Georgia, United States

🇺🇸

The Reading Hospital and Medical Center, West Reading, Pennsylvania, United States

🇺🇸

Remington-Davis, Inc., and Riverside Infection Consultants, Inc., Columbus, Ohio, United States

and more 4 locations

Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C

Phase 2
Completed
Conditions
Chronic Hepatitis C
First Posted Date
2007-01-04
Last Posted Date
2007-01-04
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
40
Registration Number
NCT00418054
Locations
🇪🇬

Department of Tropical Medicine & Infectious Diseases, Alexandria University, Alexandria, Egypt

🇪🇬

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine, Tanta, Egypt

Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

Phase 3
Terminated
Conditions
Clostridium Infections
Interventions
First Posted Date
2006-10-06
Last Posted Date
2015-05-05
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
50
Registration Number
NCT00384527
Locations
🇺🇸

Michael E. Debakey VAMC, Houston, Texas, United States

🇺🇸

Bay Pines VAMC, Bay Pines, Florida, United States

🇺🇸

John D. Dingell VAMC, Ann Arbor, Michigan, United States

and more 7 locations
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