Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000704
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Multicenter Dose Ranging Clinical Trial of 23-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Dose Ranging Clinical Trial of 23-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC
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 long-term safety and effectiveness of the drug 23-dideoxycytidine zalcitabine ddC in treating patients with AIDS or advanced AIDS related complex ARC
Recent studies show that a certain group of drugs dideoxynucleosides are effective in treating patients with HIV infection ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients ddC has been shown to be well tolerated in certain patients with AIDS
Recent studies show that a certain group of drugs dideoxynucleosides are effective in treating patients with HIV infection ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients ddC has been shown to be well tolerated in certain patients with AIDS
Detailed Description:
Recent studies show that a certain group of drugs dideoxynucleosides are effective in treating patients with HIV infection ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients ddC has been shown to be well tolerated in certain patients with AIDS
A range of doses of ddC is given to patients with AIDS and ARC Eight patients with AIDS and eight patients with ARC are given ddC at the lowest level for 12 weeks Patients who respond with a rise in their number of T4 cells or with a fall in HIV antigen in their serum the fluid portion of the blood are continued at that dose for an additional 12 weeks Patients who do not respond at a given dose level no rise in T4 or fall in serum HIV antigen stop treatment at 12 weeks All patients are followed off therapy for 4 weeks As each dose level is found to be well tolerated for 10 weeks in five of the eight patients in each group additional patients will be entered at higher dose levels until eight AIDS and eight ARC patients are receiving the drug at a given level
A range of doses of ddC is given to patients with AIDS and ARC Eight patients with AIDS and eight patients with ARC are given ddC at the lowest level for 12 weeks Patients who respond with a rise in their number of T4 cells or with a fall in HIV antigen in their serum the fluid portion of the blood are continued at that dose for an additional 12 weeks Patients who do not respond at a given dose level no rise in T4 or fall in serum HIV antigen stop treatment at 12 weeks All patients are followed off therapy for 4 weeks As each dose level is found to be well tolerated for 10 weeks in five of the eight patients in each group additional patients will be entered at higher dose levels until eight AIDS and eight ARC patients are receiving the drug at a given level
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 |
|---|---|---|---|
| 10988 | REGISTRY | DAIDS ES Registry Number | None |