Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002279
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of ddC in Patients With AIDS or Advanced AIDS-Related Complex ARC Who Have Not Had Success With Zidovudine AZT
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Dideoxycytidine Ro 24-2027 An Open-Label Safety Study of Dideoxycytidine ddC in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine AZT Therapy
Status:
COMPLETED
Status Verified Date:
1991-10
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:
AMENDED To provide ddC for patients with AIDS or advanced ARC who have failed treatment with are intolerant to or are ineligible to receive zidovudine AZT and to demonstrate that ddC monotherapy is safe and tolerable in this patient population
Original design To provide zalcitabine dideoxycytidine ddC for patients with AIDS or advanced AIDS-related complex ARC who have failed treatment with or are intolerant to zidovudine AZT and who are also intolerant to dideoxyinosine ddI to demonstrate that ddC monotherapy is safe and tolerable in the treatment of patients who previously experienced either treatment failure hematologic intolerance or myositis with AZT treatment and pancreatitis or other toxicities except peripheral neuropathy with ddI
Original design To provide zalcitabine dideoxycytidine ddC for patients with AIDS or advanced AIDS-related complex ARC who have failed treatment with or are intolerant to zidovudine AZT and who are also intolerant to dideoxyinosine ddI to demonstrate that ddC monotherapy is safe and tolerable in the treatment of patients who previously experienced either treatment failure hematologic intolerance or myositis with AZT treatment and pancreatitis or other toxicities except peripheral neuropathy with ddI
Detailed Description:
The first 50 patients enrolled into the study will be with investigators having prior ddC experience specifically AIDS Clinical Trials Group ACTG or non-ACTG investigators who are listed in ddC protocols NIAID ACTG 012 112 047 050 106 N3447 114 N3300 119 N3492 N3226 or investigators at any ACTG center or ACTG satellite centers with knowledge of ddC therapy
Once all 50 patients have been entered and 25 have completed four weeks of treatment the study will be dependent upon receipt of completed case forms up to week 4 of treatment for the 25 patients who have been reviewed and evaluated for safety
Patients 51-200 may then be entered by any physician licensed in his or her state who has experience with AIDS patients and agrees to follow the patients as specified in the protocol After all 200 have been entered and week 16 case report forms are returned to the ddC Coordinating Center and reviewed for safety for 100 of the 200 patients the protocol would be open without limit on numbers of patients
Once all 50 patients have been entered and 25 have completed four weeks of treatment the study will be dependent upon receipt of completed case forms up to week 4 of treatment for the 25 patients who have been reviewed and evaluated for safety
Patients 51-200 may then be entered by any physician licensed in his or her state who has experience with AIDS patients and agrees to follow the patients as specified in the protocol After all 200 have been entered and week 16 case report forms are returned to the ddC Coordinating Center and reviewed for safety for 100 of the 200 patients the protocol would be open without limit on numbers of patients
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 |
|---|---|---|---|
| N3544C | None | None | None |