Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000678
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
Dideoxycytidine Ro 24-2027 A Randomized Open-Label Comparative Study of Dideoxycytidine ddC Versus Zidovudine AZT in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Dideoxycytidine Ro 24-2027 A Randomized Open-Label Comparative Study of Dideoxycytidine ddC Versus Zidovudine AZT in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy
Status:
COMPLETED
Status Verified Date:
1992-09
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 compare the effectiveness of zalcitabine dideoxycytidine ddC therapy to zidovudine AZT in the treatment of AIDS or advanced AIDS related complex ARC in patients who have already received at least 1 year of AZT therapy and to define the safety profile
ddC has been shown to have an antiviral effect and AZT is known to significantly decrease mortality and to reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC After 1 year of AZT therapy the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates This may be due to the emergence of AZT resistant virus isolated from some patients who have been on long-term AZT therapy These isolates were still sensitive to ddC A study of long-term effectiveness of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is warranted because 1 ddC has antiviral activity 2 there is no blood toxicity associated with taking ddC and 3 the effectiveness of ddC in test tube studies does not seem to be diminished by decreased effectiveness of AZT
ddC has been shown to have an antiviral effect and AZT is known to significantly decrease mortality and to reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC After 1 year of AZT therapy the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates This may be due to the emergence of AZT resistant virus isolated from some patients who have been on long-term AZT therapy These isolates were still sensitive to ddC A study of long-term effectiveness of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is warranted because 1 ddC has antiviral activity 2 there is no blood toxicity associated with taking ddC and 3 the effectiveness of ddC in test tube studies does not seem to be diminished by decreased effectiveness of AZT
Detailed Description:
ddC has been shown to have an antiviral effect and AZT is known to significantly decrease mortality and to reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC After 1 year of AZT therapy the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates This may be due to the emergence of AZT resistant virus isolated from some patients who have been on long-term AZT therapy These isolates were still sensitive to ddC A study of long-term effectiveness of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is warranted because 1 ddC has antiviral activity 2 there is no blood toxicity associated with taking ddC and 3 the effectiveness of ddC in test tube studies does not seem to be diminished by decreased effectiveness of AZT
AMENDED AZT will be administered orally every 4 or 5 hours Patients in the second arm discontinue AZT and take ddC as two tablets every 8 hours Duration of the study is 1 year with interim analysis done at 6 months after 75 percent enrollment and at end of the study Original design Patients with AIDS or advanced ARC who have been receiving at least 500 mgday of AZT for at least 48 weeks are randomized to 1 of 2 treatment arms Patients in the first treatment arm continue their current dose of AZT
AMENDED AZT will be administered orally every 4 or 5 hours Patients in the second arm discontinue AZT and take ddC as two tablets every 8 hours Duration of the study is 1 year with interim analysis done at 6 months after 75 percent enrollment and at end of the study Original design Patients with AIDS or advanced ARC who have been receiving at least 500 mgday of AZT for at least 48 weeks are randomized to 1 of 2 treatment arms Patients in the first treatment arm continue their current dose of AZT
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 |
|---|---|---|---|
| N3492B | None | None | None |