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Sponsored by: |
Romark Laboratories L.C. |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002158 |
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).
Condition | Intervention |
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Cryptosporidiosis HIV Infections |
Drug: Nitazoxanide |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Open-Label Compassionate Use of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients |
Patients receive oral nitazoxanide daily for 14 days, after which those with complete clinical and parasitologic response discontinue treatment. Non-responders and partial responders may continue therapy for an additional 14 days at the discretion of the physician. Non-responders who show signs of improvement or who have partial response after 28 days and those who relapse following complete response may continue therapy for an additional month, up to 60 days total. [AS PER AMENDMENT 10/30/96: Patients receive a daily treatment for 4 weeks, with subsequent dose escalation in the absence of drug-related toxicity. Patients who exhibit complete response after 2 months may continue at a maintenance dose. Patients enrolled after October 15, 1996 are randomized to 1 of 2 doses, with subsequent escalations made in the absence of toxicity. Complete responders may continue therapy at a maintenance dose and duration determined by the investigator. Non-responders after 6 months of therapy have treatment discontinued.] [AS PER AMENDMENT 8/5/97: All patients are evaluated at Weeks 1, 2, 4, and monthly thereafter.] [AS PER AMENDMENT 8/17/99: New patients start therapy on a different dosage of nitazoxanide. Those who do not respond after 4 weeks of therapy will escalate to a higher dosage. Patients who show a complete response at 2 consecutive visits (2 weeks apart) discontinue nitazoxanide therapy and go to follow-up.] [AS PER AMENDMENT 2/3/00: The Week 1 clinical evaluation is deleted from the study procedures.]
Ages Eligible for Study: | 3 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Study ID Numbers: | 253B, UMD-95-009 |
Study First Received: | November 2, 1999 |
Last Updated: | July 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00002158 |
Health Authority: | United States: Food and Drug Administration |
Cryptosporidiosis Diarrhea Acquired Immunodeficiency Syndrome nitazoxanide Antiparasitic Agents |
Protozoan Infections Sexually Transmitted Diseases, Viral Diarrhea Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Intestinal Diseases Immunologic Deficiency Syndromes Virus Diseases |
Cryptosporidiosis Digestive System Diseases HIV Infections Sexually Transmitted Diseases Parasitic Diseases Nitazoxanide Intestinal Diseases, Parasitic Retroviridae Infections |
Anti-Infective Agents Antiparasitic Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Coccidiosis |
Therapeutic Uses Lentivirus Infections Parasitic Diseases, Animal Protozoan Infections, Animal Infection Pharmacologic Actions |