|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Treatment, Placebo Control |
| 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
| Study ID Numbers: | 038A, JRD 64,433/1101 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002027 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Cryptosporidiosis Diarrhea |
diclazuril Coccidiostats Acquired Immunodeficiency Syndrome |
|
Anti-Infective Agents Communicable Diseases Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Gastrointestinal Diseases Infection Antiparasitic Agents Cryptosporidiosis Therapeutic Uses Parasitic Diseases Parasitic Diseases, Animal Coccidiostats 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 Diclazuril Intestinal Diseases, Parasitic |