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Study 16 of 19 for search of: | "Cryptosporidiosis" |
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Sponsors and Collaborators: |
Rhone-Poulenc Rorer National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000980 |
To determine the safety and effectiveness of intravenous spiramycin in patients with AIDS-related cryptosporidial diarrhea.
Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.
Condition | Intervention | Phase |
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Cryptosporidiosis HIV Infections |
Drug: Spiramycin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea |
Estimated Enrollment: | 25 |
Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.
Patients are observed for 3 days to establish baseline conditions. They are informed that the treatment period is 21 days during which they receive 15 days of spiramycin and 6 consecutive days of placebo; they are not told which 6-day period they receive placebo. All patients receive 15 days of spiramycin. Patients who do not have a favorable response are treated with a higher dose of spiramycin for an additional 15 days. Responders at either dose are followed weekly for 4 weeks. Should a relapse occur, patients receive an additional 15 days of therapy, at the dose of spiramycin that initially produced a response, following reestablishment of a baseline with 6 days of placebo. Nonresponders to the higher dose are taken off the study.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Allowed for diarrhea:
Allowed for nausea:
Allowed for vomiting:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 7 days of study entry:
Excluded within 14 days of study entry:
United States, California | |
Kaiser Permanente Med Ctr | |
San Diego, California, United States, 92120 | |
United States, Maryland | |
Johns Hopkins Univ School of Medicine | |
Baltimore, Maryland, United States, 21205 | |
United States, Massachusetts | |
Univ of Massachusetts Med Ctr | |
Worcester, Massachusetts, United States, 01655 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Univ Hosp of Cleveland / Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
United States, Texas | |
Nelson Tebedo Community Clinic | |
Dallas, Texas, United States, 75219 |
Study Chair: | R Soave |
Study ID Numbers: | ACTG 113, FDA 28A, CCB-301 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000980 |
Health Authority: | Unspecified |
Single-Blind Method Spiramycin AIDS-Related Opportunistic Infections Injections, Intravenous |
Cryptosporidiosis Diarrhea Drug Evaluation Acquired Immunodeficiency Syndrome |
Protozoan Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Spiramycin Intestinal Diseases Immunologic Deficiency Syndromes |
Virus Diseases Signs and Symptoms Cryptosporidiosis Digestive System Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Parasitic Diseases Intestinal Diseases, Parasitic Retroviridae Infections |
Anti-Infective Agents Antiprotozoal Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Coccidiosis Infection Pharmacologic Actions |
Anti-Bacterial Agents Antiparasitic Agents Therapeutic Uses Lentivirus Infections Protozoan Infections, Animal Parasitic Diseases, Animal Coccidiostats |