HIV Infections Clinical Trial
Official title:
Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea
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.
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.
;
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