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Sponsored by: |
Janssen, LP |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002027 |
To evaluate the safety and efficacy of diclazuril capsules compared with placebo capsules as treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be based on the drug's clinical results and on its anti-protozoan effects. Safety will be assessed by the occurrence of side effects as reported by patients at their visits and by frequent monitoring of hematology, biochemistries, and urinalysis.
Condition | Intervention |
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Cryptosporidiosis HIV Infections |
Drug: Diclazuril |
Study Type: | Interventional |
Study Design: | Treatment, Placebo Control |
Official Title: | Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433) |
Ages Eligible for Study: | 12 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 15 days of study entry:
Prior Treatment:
Excluded within 15 days of study entry:
United States, New York | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
Saint Luke's - Roosevelt Hosp Ctr | |
New York, New York, United States, 10025 | |
Dr Douglas Dieterich | |
New York, New York, United States, 10016 |
Study ID Numbers: | 038A, JRD 64,433/1101 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002027 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Cryptosporidiosis Diarrhea |
diclazuril Coccidiostats Acquired Immunodeficiency Syndrome |
Protozoan Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Diarrhea 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 Diclazuril Parasitic Diseases Intestinal Diseases, Parasitic Retroviridae Infections |
Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Immune System Diseases Coccidiosis Infection |
Pharmacologic Actions Antiparasitic Agents Therapeutic Uses Lentivirus Infections Protozoan Infections, Animal Parasitic Diseases, Animal Coccidiostats |