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Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Rhone-Poulenc Rorer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002062
  Purpose

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

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  • Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Concurrent Medication:

Excluded:

  • Other investigational drugs.

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.

  • Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Prior Medication:

Excluded within 7 days of study entry:

  • Other investigational drugs.

Diagnosis of chronic diarrhea due to cryptosporidiosis and a compromised immune system but not limited to patients with AIDS.

  • Patients receiving chemotherapy for a malignancy.
  • Patients who are iatrogenically immune-suppressed following organ transplantation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002062

Locations
United States, Pennsylvania
Rhone - Poulenc Rorer Pharmaceuticals
Horsham, Pennsylvania, United States, 19044
Sponsors and Collaborators
Rhone-Poulenc Rorer
  More Information

No publications provided

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

Keywords provided by NIH AIDS Clinical Trials Information Service:
Spiramycin
AIDS-Related Opportunistic Infections
Immune Tolerance
Cryptosporidiosis
Diarrhea
Drugs, Investigational
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 02, 2009