Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000963
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of Dideoxyinosine ddI in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Comparative Trial of Two Doses of 23-Dideoxyinosine ddI in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine andor Who Are Intolerant to Zidovudine
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 evaluate the effectiveness safety and tolerance of two doses of didanosine ddI in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine AZT because of intolerance andor who have experienced progressive disease while on AZT
The progression of immunodeficiency due to HIV infection can be delayed by using AZT The benefits of AZT in adults with AIDS and severe AIDS-related complex ARC appear to last for approximately 12 to 18 months at which time most patients have progressive deterioration Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment Although the clinical significance of this is unclear it makes the development of new antiretroviral drugs important
The progression of immunodeficiency due to HIV infection can be delayed by using AZT The benefits of AZT in adults with AIDS and severe AIDS-related complex ARC appear to last for approximately 12 to 18 months at which time most patients have progressive deterioration Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment Although the clinical significance of this is unclear it makes the development of new antiretroviral drugs important
Detailed Description:
The progression of immunodeficiency due to HIV infection can be delayed by using AZT The benefits of AZT in adults with AIDS and severe AIDS-related complex ARC appear to last for approximately 12 to 18 months at which time most patients have progressive deterioration Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment Although the clinical significance of this is unclear it makes the development of new antiretroviral drugs important
Children who show AZT intolerance andor progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks with a 48-week extension Patients are seen for clinical and laboratory evaluations at scheduled times during the study Per 51292 amendment new patients will not be enrolled in the pharmacokinetics studies Per 103194 amendment Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit but no later than 21595
Children who show AZT intolerance andor progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks with a 48-week extension Patients are seen for clinical and laboratory evaluations at scheduled times during the study Per 51292 amendment new patients will not be enrolled in the pharmacokinetics studies Per 103194 amendment Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit but no later than 21595
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 |
|---|---|---|---|
| 11119 | REGISTRY | DAIDS ES Registry Number | None |