NCT00000980

A Study of Spiramycin in the Treatment of Patients With AIDS-Related Diarrhea

Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (planned)
• Sponsor: Rhone-Poulenc Rorer · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and effectiveness of intravenous spiramycin in patients with AIDS-related cryptosporidial diarrhea. Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.

Detailed description

Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin. Patients are observed for 3 days to establish baseline conditions. They are informed that the treatment period is 21 days during which they receive 15 days of spiramycin and 6 consecutive days of placebo; they are not told which 6-day period they receive placebo. All patients receive 15 days of spiramycin. Patients who do not have a favorable response are treated with a higher dose of spiramycin for an additional 15 days. Responders at either dose are followed weekly for 4 weeks. Should a relapse occur, patients receive an additional 15 days of therapy, at the dose of spiramycin that initially produced a response, following reestablishment of a baseline with 6 days of placebo. Nonresponders to the higher dose are taken off the study.

Conditions

• Cryptosporidiosis
• HIV Infections

Interventions

Type	Name	Description
DRUG	Spiramycin

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

7 sites across 1 country: United States