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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002062
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1991
  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: Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00002062     History of Changes
Other Study ID Numbers: 011A, CCA 901
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cryptosporidiosis
Diarrhea
HIV Infections
Infection
Coccidiosis
Digestive System Diseases
Gastrointestinal Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Intestinal Diseases
Intestinal Diseases, Parasitic
Lentivirus Infections
Parasitic Diseases
Parasitic Diseases, Animal
Protozoan Infections
Protozoan Infections, Animal
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Signs and Symptoms, Digestive
Slow Virus Diseases
Virus Diseases
Spiramycin
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents

ClinicalTrials.gov processed this record on November 27, 2014