Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002158
Status:
UNKNOWN
Last Update Posted:
2007-07-10
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis
Sponsor:
Romark Laboratories LC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Open-Label Compassionate Use of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 nitazoxanide NTZ can be used to treat AIDS patients suffering from cryptosporidiosis diarrhea caused by the parasite Cryptosporidium
Detailed Description:
Patients receive oral nitazoxanide daily for 14 days after which those with complete clinical and parasitologic response discontinue treatment Non-responders and partial responders may continue therapy for an additional 14 days at the discretion of the physician Non-responders who show signs of improvement or who have partial response after 28 days and those who relapse following complete response may continue therapy for an additional month up to 60 days total AS PER AMENDMENT 103096 Patients receive a daily treatment for 4 weeks with subsequent dose escalation in the absence of drug-related toxicity Patients who exhibit complete response after 2 months may continue at a maintenance dose Patients enrolled after October 15 1996 are randomized to 1 of 2 doses with subsequent escalations made in the absence of toxicity Complete responders may continue therapy at a maintenance dose and duration determined by the investigator Non-responders after 6 months of therapy have treatment discontinued AS PER AMENDMENT 8597 All patients are evaluated at Weeks 1 2 4 and monthly thereafter AS PER AMENDMENT 81799 New patients start therapy on a different dosage of nitazoxanide Those who do not respond after 4 weeks of therapy will escalate to a higher dosage Patients who show a complete response at 2 consecutive visits 2 weeks apart discontinue nitazoxanide therapy and go to follow-up AS PER AMENDMENT 2300 The Week 1 clinical evaluation is deleted from the study procedures
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 |
|---|---|---|---|
| UMD-95-009 | None | None | None |