Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Rhone-Poulenc Rorer |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002062 |
This protocol provides for the availability of spiramycin under compassionate-use conditions for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised immune system, thus deriving additional information regarding its safety and efficacy profile.
Condition | Intervention |
---|---|
Cryptosporidiosis HIV Infections |
Drug: Spiramycin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Exclusion Criteria
Co-existing Condition:
Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.
Concurrent Medication:
Excluded:
Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.
Prior Medication:
Excluded within 7 days of study entry:
Diagnosis of chronic diarrhea due to cryptosporidiosis and a compromised immune system but not limited to patients with AIDS.
Study ID Numbers: | 011A, CCA 901 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002062 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Spiramycin AIDS-Related Opportunistic Infections Immune Tolerance Cryptosporidiosis |
Diarrhea Drugs, Investigational Acquired Immunodeficiency Syndrome |
Anti-Infective Agents Protozoan Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Diarrhea Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Spiramycin Intestinal Diseases Immunologic Deficiency Syndromes |
Virus Diseases Anti-Bacterial Agents 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 Sexually Transmitted Diseases, Viral Slow Virus Diseases Gastrointestinal Diseases Spiramycin Infection Anti-Bacterial Agents 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 Intestinal Diseases, Parasitic |