Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004986
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2000-03-16
Brief Title:
Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
Sponsor:
Romark Laboratories LC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Open Label Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States
Status:
TERMINATED
Status Verified Date:
2000-08
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:
The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide
Detailed Description:
Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response therapeutic cure after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits Weeks 2 and 4 or Weeks 4 and 6 These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2 4 and 6 after completion of nitazoxanide therapy Patients who do not show a complete clinical and parasitologic response therapeutic failure after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients UMD-95-009 protocol
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 |
|---|---|---|---|
| RM-NTZ-99-003 | None | None | None |