Trials / Completed
CompletedNCT00002191
A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- SmithKline Beecham · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Albendazole |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002191. Inclusion in this directory is not an endorsement.