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| Sponsor: | Janssen, LP |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002027 |
Purpose
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 |
|---|---|
|
Cryptosporidiosis HIV Infections |
Drug: Diclazuril |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433) |
Eligibility| 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:
Contacts and Locations| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002027 History of Changes |
| Other Study ID Numbers: | 038A, JRD 64,433/1101 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Cryptosporidiosis Diarrhea |
diclazuril Coccidiostats Acquired Immunodeficiency Syndrome |
|
HIV Infections Acquired Immunodeficiency Syndrome Cryptosporidiosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Intestinal Diseases, Parasitic Parasitic Diseases |
Protozoan Infections, Animal Parasitic Diseases, Animal Coccidiosis Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Diclazuril Coccidiostats Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |