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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: | NCT00004986 |
The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.
Condition | Intervention | Phase |
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Cryptosporidiosis HIV Infections |
Drug: Nitazoxanide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States |
Estimated Enrollment: | 30 |
Study Start Date: | February 2000 |
Patients take nitazoxanide daily for 8 weeks with a dose
escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.
Ages Eligible for Study: | 13 Years and older |
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 if they:
Study ID Numbers: | 253C, RM-NTZ-99-003 |
Study First Received: | March 16, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004986 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Cryptosporidiosis Drug Evaluation |
Antiprotozoal Agents Treatment Failure nitazoxanide |
Protozoan Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Intestinal Diseases Immunologic Deficiency Syndromes Virus Diseases Cryptosporidiosis |
Digestive System Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Parasitic Diseases Nitazoxanide Intestinal Diseases, Parasitic Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Gastrointestinal Diseases Infection Cryptosporidiosis Antiparasitic Agents Therapeutic Uses Parasitic Diseases Parasitic Diseases, Animal Retroviridae Infections Protozoan Infections RNA Virus Infections Immune System Diseases |
Coccidiosis Acquired Immunodeficiency Syndrome Intestinal Diseases Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Protozoan Infections, Animal Intestinal Diseases, Parasitic Nitazoxanide |