Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000657
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Comparison of 23-Dideoxyinosine Didanosine ddI and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Comparison of 23-Dideoxyinosine Didanosine ddI and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
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 compare the safety and effectiveness of orally administered didanosine ddI with high dose orally administered zidovudine AZT in patients who develop or exhibit progression of the AIDS dementia complex ADC and who have not previously been intolerant to AZT at doses of up to 1000 mgday
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system ADC may be caused by some action of the AIDS virus on the nervous system although similar problems can be caused by other infections because the AIDS virus lowers the bodys ability to fight other infections It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system ADC may be caused by some action of the AIDS virus on the nervous system although similar problems can be caused by other infections because the AIDS virus lowers the bodys ability to fight other infections It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC
Detailed Description:
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system ADC may be caused by some action of the AIDS virus on the nervous system although similar problems can be caused by other infections because the AIDS virus lowers the bodys ability to fight other infections It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC
Patients are randomly assigned to receive either oral ddI or oral AZT
Patients are randomly assigned to receive either oral ddI or oral AZT
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 |
|---|---|---|---|
| 11115 | REGISTRY | DAIDS ES Registry Number | None |