Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000651
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
A Randomized Double Blind Comparative Study of Dideoxycytidine ddC Alone or ddCAZT Combination Versus Zidovudine ZDV Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double Blind Comparative Study of Dideoxycytidine ddC Alone or ddCAZT Combination Versus Zidovudine ZDV Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
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 safety of zalcitabine dideoxycytidine ddC alone and in combination with zidovudine AZT versus AZT alone when administered to asymptomatic patients with a CD4 count or 200 cellsmm3 and symptomatic patients with a CD4 count or 300 cellsmm3 To compare the effectiveness of ddC alone and in combination with AZT versus AZT alone
ddC has been shown to demonstrate an antiviral effect AZT has been shown to significantly decrease mortality and 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 Because of the demonstrated antiviral activity absence of hematologic toxicity and lack of cross tolerance in laboratory studies of ddC a study to investigate the long-term effectiveness of ddC in patients with HIV infection who have received AZT therapy is warranted
ddC has been shown to demonstrate an antiviral effect AZT has been shown to significantly decrease mortality and 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 Because of the demonstrated antiviral activity absence of hematologic toxicity and lack of cross tolerance in laboratory studies of ddC a study to investigate the long-term effectiveness of ddC in patients with HIV infection who have received AZT therapy is warranted
Detailed Description:
ddC has been shown to demonstrate an antiviral effect AZT has been shown to significantly decrease mortality and 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 Because of the demonstrated antiviral activity absence of hematologic toxicity and lack of cross tolerance in laboratory studies of ddC a study to investigate the long-term effectiveness of ddC in patients with HIV infection who have received AZT therapy is warranted
Patients are randomly assigned to 1 of 3 treatment groups In study arm 1 patients receive AZT plus ddC placebo In study arm 2 patients receive ddC plus AZT placebo capsules In study arm 3 patients receive ddC plus AZT Patients are seen every other week for first 8 weeks and monthly thereafter Patients are stratified by HIV disease status length of time receiving AZT and systemic or local Pneumocystis carinii pneumonia PCP prophylaxis Patients who reach a clinical AIDS-defining endpoint are offered open-label combination therapy
Patients are randomly assigned to 1 of 3 treatment groups In study arm 1 patients receive AZT plus ddC placebo In study arm 2 patients receive ddC plus AZT placebo capsules In study arm 3 patients receive ddC plus AZT Patients are seen every other week for first 8 weeks and monthly thereafter Patients are stratified by HIV disease status length of time receiving AZT and systemic or local Pneumocystis carinii pneumonia PCP prophylaxis Patients who reach a clinical AIDS-defining endpoint are offered open-label combination therapy
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 |
|---|---|---|---|
| 11130 | REGISTRY | DAIDS ES Registry Number | None |