Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002191
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Double-Blind Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis
Sponsor:
SmithKline Beecham
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis
Status:
COMPLETED
Status Verified Date:
1997-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GHBA 659 | None | None | None |
| SK 62979029 | None | None | None |