A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis

Launched by SMITHKLINE BEECHAM · Aug 30, 2001

Keywords

ClinConnect Summary

In the double-blind portion of study, patients receive albendazole or placebo for 28 days; in the open-label portion of study, patients receive albendazole for 62 days.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Required:
• • If coincident enteric pathogens that are not eradicable (i.e., Mycobacterium avium complex) are detected, they should be treated appropriately and the patient must be on a stable regimen of therapy for at least two weeks.
• Allowed:
• • Patients taking antidiarrheal medications must be on a stable regimen for at least seven days prior to randomization.
• • Patients taking other concomitant medications, including antiretrovirals, must be on a stable regimen for two weeks prior to randomization.
• Patients must have:
• • HIV positive status. Written documentation (for example, patient's chart) of HIV diagnosis is acceptable in lieu of repeat testing. Confirmation by Western blot is not necessary.
• • Biopsy-proven microsporidiosis of the fourth portion of the duodenum or proximal jejunum within 90 days before randomization.
• * Average of \> 3 liquid bowel movements per day over 7 consecutive days immediately prior to randomization, with an average volume \> 500 ml per day over three or more consecutive days immediately prior to randomization, as documented by data collected in a daily diary. NOTE:
• • Patients receiving antidiarrheal therapy must meet these criteria despite such therapy.
• • History of an average of \> 3 liquid bowel movements per day for three additional weeks immediately preceding the 7-day period described above (for a total of four weeks), as documented in the patient's chart.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Grade 4 neutropenia.
• • Decompensated liver disease.
• • Positive toxin analysis for C. difficile.
• • Positive microscopic examination for Giardia lamblia, Entamoeba histolytica, and Isospora belli.
• • Positive on culture for Shigella, Salmonella, Yersinia and Campylobacter.
• • Positive fluorescent antibody test for Cryptosporidium.
• • Evidence of CMV on small bowel biopsy, flexible sigmoidoscopic or colonoscopic biopsies within 90 days of randomization.
• • Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study entry.
• Patients with the following prior conditions are excluded:
• • Hypersensitivity to albendazole.
• Prior Medication:
• Excluded:
• • Use of potential antiprotozoal drugs, e.g., mebendazole or metronidazole, within one week prior to enrollment.
• • Receipt of albendazole during the one month prior to enrollment.