Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002444
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
Sponsor:
Unimed Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Phase III Open Label Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
Status:
COMPLETED
Status Verified Date:
1996-02
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 determine the pharmacokinetics profile of single doses of nitazoxanide NTZ in patients with AIDS-related cryptosporidial diarrhea To determine steady state concentrations of NTZ following repeated dosing To assess the safety and efficacy of 4 dose levels of NTZ in these patients
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe contributing substantially to morbidity mortality and health care costs in this population NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe contributing substantially to morbidity mortality and health care costs in this population NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection
Detailed Description:
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe contributing substantially to morbidity mortality and health care costs in this population NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection
Patients are enrolled in groups of 7 Group A receives the lowest dose of NTZ Groups B - D receive sequentially higher doses Patients in Groups B - D do not begin therapy until all patients have been enrolled at the preceding dose For determination of single-dose pharmacokinetics patients receive a single dose of NTZ on Day 1 and blood samples are obtained over the next 24 hours Immediately following the 24-hour blood sample collection patients begin the treatment phase during which they take NTZ for an additional 13 days Blood samples are obtained again on Day 14 to determine full plasma concentration-time profiles over the dosing interval At the end of treatment responders discontinue treatment and nonresponders continue NTZ treatment for an additional 14 days on the same dose Patients who still fail to respond are provided with an additional month of NTZ Patients have scheduled visits for clinical and parasitologic efficacy assessments and safety laboratory tests
Patients are enrolled in groups of 7 Group A receives the lowest dose of NTZ Groups B - D receive sequentially higher doses Patients in Groups B - D do not begin therapy until all patients have been enrolled at the preceding dose For determination of single-dose pharmacokinetics patients receive a single dose of NTZ on Day 1 and blood samples are obtained over the next 24 hours Immediately following the 24-hour blood sample collection patients begin the treatment phase during which they take NTZ for an additional 13 days Blood samples are obtained again on Day 14 to determine full plasma concentration-time profiles over the dosing interval At the end of treatment responders discontinue treatment and nonresponders continue NTZ treatment for an additional 14 days on the same dose Patients who still fail to respond are provided with an additional month of NTZ Patients have scheduled visits for clinical and parasitologic efficacy assessments and safety laboratory tests
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-95-004 | None | None | None |