Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002265
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
An Open-Label Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine ddC in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine AZT in Protocol N3300 or N3492
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine ddC in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine AZT in Protocol N3300 or N3492
Status:
COMPLETED
Status Verified Date:
1994-02
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 demonstrate that zalcitabine dideoxycytidine ddC monotherapy is safe and tolerable in the treatment of patients with AIDS or advanced AIDS related complex ARC who previously demonstrated intolerance to zidovudine AZT treatment while in Protocol N3300 NIAID ACTG 114 or N3492 NIAID ACTG 119
NOTE OF CAUTION FOR CONCOMITANT MEDICATIONS ON STUDY
Patients on amphotericin pyrimethamine sulfadiazine trimethoprimsulfamethoxazole ganciclovir intravenous pentamidine intravenous acyclovir or oral acyclovir or other bone marrow or renal toxic drugs may not tolerate concomitant ddC If these drugs are given concomitantly with ddC patients should have frequent clinical and laboratory assessments as appropriate Drugs that are nephrotoxic or have the potential to cause peripheral neuropathy might be expected to cause increased toxicity when co-administered with ddC Drugs that could cause serious additive toxicity when co-administered with study medication will be allowed for treatment of an acute intercurrent illness or opportunistic infection at the discretion of the investigator Their use may be allowed with interruption of study drug for up to 35 days per episode for a total of 90 days for the study If the patients condition requires chronic administration of these medications the patient will be discontinued from study medication and followed
NOTE OF CAUTION FOR CONCOMITANT MEDICATIONS ON STUDY
Patients on amphotericin pyrimethamine sulfadiazine trimethoprimsulfamethoxazole ganciclovir intravenous pentamidine intravenous acyclovir or oral acyclovir or other bone marrow or renal toxic drugs may not tolerate concomitant ddC If these drugs are given concomitantly with ddC patients should have frequent clinical and laboratory assessments as appropriate Drugs that are nephrotoxic or have the potential to cause peripheral neuropathy might be expected to cause increased toxicity when co-administered with ddC Drugs that could cause serious additive toxicity when co-administered with study medication will be allowed for treatment of an acute intercurrent illness or opportunistic infection at the discretion of the investigator Their use may be allowed with interruption of study drug for up to 35 days per episode for a total of 90 days for the study If the patients condition requires chronic administration of these medications the patient will be discontinued from study medication and followed
Detailed Description:
None
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 |
|---|---|---|---|
| N3526A | None | None | None |