Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
Cryptosporidiosis, HIV Infections
About this trial
This is an interventional treatment trial for Cryptosporidiosis focused on measuring Spiramycin, AIDS-Related Opportunistic Infections, Immune Tolerance, Cryptosporidiosis, Diarrhea, Drugs, Investigational, Acquired Immunodeficiency Syndrome
Eligibility 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.
Sites / Locations
- Rhone - Poulenc Rorer Pharmaceuticals