Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055107
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2003-02-19
Brief Title:
Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Open Label Study of Nitazoxanide NTZ for the Treatment of Cryptosporidium Parvum in HIV Infected Infants Children and Adolescents
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:
Cryptosporidium parvum C parvum is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries C parvum infection can be treated with the drug nitazoxanide NTZ However NTZ has not been tested in HIV infected children The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C parvum
Study hypothesis Twice-daily NTZ is safe and well tolerated in HIV infected infants children and adolescents with chronic diarrhea caused by C parvum infection
Study hypothesis Twice-daily NTZ is safe and well tolerated in HIV infected infants children and adolescents with chronic diarrhea caused by C parvum infection
Detailed Description:
C parvum is a significant opportunistic infection in much of the developing world where children may not have access to highly active antiretroviral therapy There is currently no established therapy for chronic cryptosporidiosis in HIV infected children The FDA has approved NTZ for the treatment of cryptosporidiosis diarrhea however there are no data on the safety and effectiveness of NTZ in HIV infected children The purpose of this study is to evaluate the safety of different doses of NTZ in HIV infected children with chronic diarrhea caused by C parvum
In Step 1 participants will receive one of four different doses of NTZ Participants will take NTZ twice a day for 56 days in either a liquid or pill form All participants will be closely monitored for drug toxicity There will be seven study visits they will occur at study entry Weeks 1 2 4 6 and 8 and Day 70 Study visits will include a physical exam and blood urine and stool collection Pharmacokinetic PK sampling will be performed during four of the study visits PK sampling requires the participants to take their morning NTZ doses while in the clinic participants will undergo additional blood collection either before or after taking NTZ At the end of the 56-day study period participants who are experiencing a positive clinical benefit from NTZ and who have had no harmful side effects may choose to continue taking NTZ for an additional 24 weeks and enter Step 2 Participants who do not continue taking NTZ after Day 56 will be followed for 2 additional weeks
In Step 1 participants will receive one of four different doses of NTZ Participants will take NTZ twice a day for 56 days in either a liquid or pill form All participants will be closely monitored for drug toxicity There will be seven study visits they will occur at study entry Weeks 1 2 4 6 and 8 and Day 70 Study visits will include a physical exam and blood urine and stool collection Pharmacokinetic PK sampling will be performed during four of the study visits PK sampling requires the participants to take their morning NTZ doses while in the clinic participants will undergo additional blood collection either before or after taking NTZ At the end of the 56-day study period participants who are experiencing a positive clinical benefit from NTZ and who have had no harmful side effects may choose to continue taking NTZ for an additional 24 weeks and enter Step 2 Participants who do not continue taking NTZ after Day 56 will be followed for 2 additional weeks
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 |
|---|---|---|---|
| 10033 | REGISTRY | DAIDS ES | None |