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

Phase 3

Completed

• Conditions: Protozoan Infections; HIV Infections

• Registration Number: NCT00002191
• Lead Sponsor: SmithKline Beecham

Brief Summary

To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole, administered for 28 days, compared to placebo and for 62 days in open-label fashion, in treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and on the relationship between microsporidial counts in stool and stool frequency and volume. To correlate microsporidial counts with the clinical course of microsporidiosis.

Detailed Description

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.

Study Timeline

• Status Verified: 1997-07
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

San Francisco Gen Hosp / Div of GI; 🇺🇸 San Francisco, California, United States

Davies Med Ctr; 🇺🇸 San Francisco, California, United States

George Washington Univ 5-403A; 🇺🇸 Washington, District of Columbia, United States

Deaconess Hosp / Harvard Med School / Infect Disease; 🇺🇸 Boston, Massachusetts, United States

New York Univ; 🇺🇸 New York, New York, United States

Saint Luke's Hosp / Services and Research 1301; 🇺🇸 New York, New York, United States