Cryptosporidiosis, HIV Infections
Conditions
Keywords
Spiramycin, AIDS-Related Opportunistic Infections, Immune Tolerance, Cryptosporidiosis, Diarrhea, Drugs, Investigational, Acquired Immunodeficiency Syndrome
Brief summary
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.
Interventions
Sponsors
Study design
Eligibility
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.
Countries
United States