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Sponsored by: |
Rhone-Poulenc Rorer |
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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 |
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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 |
Health Authority: | United States: Food and Drug Administration |
Spiramycin AIDS-Related Opportunistic Infections Immune Tolerance Cryptosporidiosis |
Diarrhea Drugs, Investigational Acquired Immunodeficiency Syndrome |
Protozoan Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Diarrhea Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Spiramycin Intestinal Diseases Immunologic Deficiency Syndromes |
Virus Diseases 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 |