Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000653
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
1999-11-02
Brief Title:
A Trial of Two Doses of 23-Dideoxycytidine ddC in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT andor Who Show Progressive Disease While on AZT
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Trial of Two Doses of 23-Dideoxycytidine ddC in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT andor Who Show Progressive Disease While on AZT
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 and compare the long-term 48-177 weeks safety tolerance and efficacy of two doses of zalcitabine dideoxycytidine ddC taken orally every 8 hours in children with symptomatic HIV infection who have one of the following intolerance to zidovudine AZT development of toxicity during prolonged AZT therapy demonstrated disease progression after 6 months of AZT therapy OR both AZT intolerance and disease progression after 6 months of AZT therapy
As useful as AZT appears to be in the treatment of patients infected with HIV it is associated with significant toxicity in some patients and it does not prevent ultimate progression to AIDS and eventual mortality Thus there is a clear need for new antiretroviral drugs and ddC is one such promising agent
As useful as AZT appears to be in the treatment of patients infected with HIV it is associated with significant toxicity in some patients and it does not prevent ultimate progression to AIDS and eventual mortality Thus there is a clear need for new antiretroviral drugs and ddC is one such promising agent
Detailed Description:
As useful as AZT appears to be in the treatment of patients infected with HIV it is associated with significant toxicity in some patients and it does not prevent ultimate progression to AIDS and eventual mortality Thus there is a clear need for new antiretroviral drugs and ddC is one such promising agent
Patients receive oral ddC for 48 to 177 weeks
Patients receive oral ddC for 48 to 177 weeks
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 |
|---|---|---|---|
| 11113 | REGISTRY | DAIDS ES Registry Number | None |