Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients - Full Text View

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

MedlinePlus related topics: AIDS Cryptosporidiosis Diarrhea

Drug Information available for: Spiramycin

U.S. FDA Resources

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

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

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

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:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009