Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001018
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Letrazuril in the Treatment of AIDS-Related Diarrhea
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Blinded Placebo-Controlled Single-Dose Pharmacokinetics and Dose Escalation Efficacy and Safety Study of Letrazuril for AIDS-Related Cryptosporidial Diarrhea
Status:
COMPLETED
Status Verified Date:
1992-10
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 pharmacokinetic profile of single doses of letrazuril in patients with AIDS-related cryptosporidial diarrhea to determine the dose proportionality of single escalating doses of letrazuril to determine steady-state concentrations of letrazuril to evaluate the safety and efficacy of escalating doses of letrazuril compared with placebo for patients with AIDS-related cryptosporidial diarrhea
Letrazuril the p-fluor analog of diclazuril has been shown in an animal model to prevent infections by organisms closely related to the intracellular parasite Cryptosporidium Reliable data are needed to show the effectiveness of letrazuril in treating AIDS-related cryptosporidial diarrhea
Letrazuril the p-fluor analog of diclazuril has been shown in an animal model to prevent infections by organisms closely related to the intracellular parasite Cryptosporidium Reliable data are needed to show the effectiveness of letrazuril in treating AIDS-related cryptosporidial diarrhea
Detailed Description:
Letrazuril the p-fluor analog of diclazuril has been shown in an animal model to prevent infections by organisms closely related to the intracellular parasite Cryptosporidium Reliable data are needed to show the effectiveness of letrazuril in treating AIDS-related cryptosporidial diarrhea
Four groups of eight patients receive escalating doses of oral letrazuril or placebo In each group six patients are randomized to receive letrazuril and two patients receive matching placebo In the pharmacokinetics determination phase of the study patients receive a single dose of letrazuril or placebo following a meal Following a 72-hour blood collection patients enter the blinded treatment phase of the study and receive letrazuril or placebo as a single dose daily after a meal for 3 weeks Patients with persistent Cryptosporidium oocysts in their stools at the end of the blinded treatment phase may continue with open-label treatment of letrazuril at the same dose for 4 weeks the dose may subsequently be escalated every 4 weeks to a maximum if oocysts persist Patients who have Cryptosporidium oocysts eradicated from their stools will discontinue treatment and be followed for 3 months All patients undergo clinical follow-up at 3 and 6 months
Four groups of eight patients receive escalating doses of oral letrazuril or placebo In each group six patients are randomized to receive letrazuril and two patients receive matching placebo In the pharmacokinetics determination phase of the study patients receive a single dose of letrazuril or placebo following a meal Following a 72-hour blood collection patients enter the blinded treatment phase of the study and receive letrazuril or placebo as a single dose daily after a meal for 3 weeks Patients with persistent Cryptosporidium oocysts in their stools at the end of the blinded treatment phase may continue with open-label treatment of letrazuril at the same dose for 4 weeks the dose may subsequently be escalated every 4 weeks to a maximum if oocysts persist Patients who have Cryptosporidium oocysts eradicated from their stools will discontinue treatment and be followed for 3 months All patients undergo clinical follow-up at 3 and 6 months
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 |
|---|---|---|---|
| Protocol JRD 657311001 | None | None | None |