Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002118
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
An Open-Label Safety Program for the Use of Zalcitabine Dideoxycytidine ddC in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy or Who Have Completed Other ddC Protocols or Are Ineligible for Other Ongoing Clinical Studies
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Safety Program for the Use of Zalcitabine Dideoxycytidine ddC in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy or Who Have Completed Other ddC Protocols or Are Ineligible for Other Ongoing Clinical Studies
Status:
COMPLETED
Status Verified Date:
1997-08
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 allow on a compassionate use basis zalcitabine ddC for pediatric patients with symptomatic HIV disease who have failed treatment or who are intolerant to zidovudine AZT or who have completed other ddC protocols or who are ineligible for ongoing clinical trials
Detailed Description:
Patients receive ddC and are evaluated at study entry and every 3 months thereafter until 3 months after ddC becomes approved for pediatric patients or the sponsor deems it necessary to terminate the protocol
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 |
|---|---|---|---|
| NV14610 | None | None | None |