Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001081
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Nitazoxanide in Patients With AIDS and Diarrhea Caused by Cryptosporidium
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase IIIII Placebo-Controlled Study of Nitazoxanide NTZ For Persons With AIDS and Cryptosporidiosis
Status:
COMPLETED
Status Verified Date:
2021-10
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 frequency of complete marked and partial clinical responses in patients with cryptosporidiosis treated with 6 weeks of NTZ versus 21 days of placebo To determine the safety of NTZ in subjects with cryptosporidiosis
There is no proven therapy for cryptosporidiosis in persons with AIDS Nitazoxanide appears to be a good candidate drug for further evaluation because of its effectiveness in preclinical models the data from early clinical trials and its safety profile Cooperation between clinical researchers and basic scientists in clinical trials of agents for HIV infection and its complications is a high priority for the ACTG the NIAID and the NIH Thus it is important to design a clinical trial of NTZ that includes cooperation with basic scientists
There is no proven therapy for cryptosporidiosis in persons with AIDS Nitazoxanide appears to be a good candidate drug for further evaluation because of its effectiveness in preclinical models the data from early clinical trials and its safety profile Cooperation between clinical researchers and basic scientists in clinical trials of agents for HIV infection and its complications is a high priority for the ACTG the NIAID and the NIH Thus it is important to design a clinical trial of NTZ that includes cooperation with basic scientists
Detailed Description:
There is no proven therapy for cryptosporidiosis in persons with AIDS Nitazoxanide appears to be a good candidate drug for further evaluation because of its effectiveness in preclinical models the data from early clinical trials and its safety profile Cooperation between clinical researchers and basic scientists in clinical trials of agents for HIV infection and its complications is a high priority for the ACTG the NIAID and the NIH Thus it is important to design a clinical trial of NTZ that includes cooperation with basic scientists
Patients will be randomized to the active drug or placebo in a 21 ratio Patients will be stratified by presence or absence of dual infection with microsporidiosis and screening CD4 count 50mm3 50mm3
Days 1 - 21 Arm I will receive oral NTZ and Arm II will receive NTZ placebo po bid blinded With the approval of the protocol chair patients may switch to open-label NTZ after two weeks of blinded therapy if there is a clinical worsening of diarrhea due to cryptosporidiosis accompanied by either weight loss 5 or the requirement for intravenous fluids to maintain body weight andor intravascular volume despite the use of appropriate antidiarrheal agents
Days 22 - 42 Arm I and Arm II will receive oral NTZ open-label Days 43 - 63 Arm I will begin the maintenance phase and Arm II will receive oral NTZ open-label
On Day 63 Arm II will start the maintenance phase In maintenance phase patients will be randomized to 1 of 2 doses of NTZ 24 weeks
Patients who are not complete or marked responders at Day 42 Arm I or Day 63 Arm II may receive a higher dose of NTZ for an additional three weeks Patients who have a complete or marked response at the higher dose may initiate maintenance therapy Patients who continue to have only a partial response or who fail to respond will discontinue therapy
Patients will be randomized to the active drug or placebo in a 21 ratio Patients will be stratified by presence or absence of dual infection with microsporidiosis and screening CD4 count 50mm3 50mm3
Days 1 - 21 Arm I will receive oral NTZ and Arm II will receive NTZ placebo po bid blinded With the approval of the protocol chair patients may switch to open-label NTZ after two weeks of blinded therapy if there is a clinical worsening of diarrhea due to cryptosporidiosis accompanied by either weight loss 5 or the requirement for intravenous fluids to maintain body weight andor intravascular volume despite the use of appropriate antidiarrheal agents
Days 22 - 42 Arm I and Arm II will receive oral NTZ open-label Days 43 - 63 Arm I will begin the maintenance phase and Arm II will receive oral NTZ open-label
On Day 63 Arm II will start the maintenance phase In maintenance phase patients will be randomized to 1 of 2 doses of NTZ 24 weeks
Patients who are not complete or marked responders at Day 42 Arm I or Day 63 Arm II may receive a higher dose of NTZ for an additional three weeks Patients who have a complete or marked response at the higher dose may initiate maintenance therapy Patients who continue to have only a partial response or who fail to respond will discontinue therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10690 | REGISTRY | DAIDS ES | None |