Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000754
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Randomized Phase II Study of Two Doses of Interferon Alfa-2a IFN Alfa-2a in Combination With Zidovudine AZT and Dideoxycytidine ddC Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Phase II Study of Two Doses of Interferon Alfa-2a IFN Alfa-2a in Combination With Zidovudine AZT and Dideoxycytidine ddC Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cellsmm3
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 determine the safety and efficacy of two doses of interferon alfa-2a IFN alfa-2a in combination with zidovudine AZT zalcitabine ddC versus AZTddC only in patients with HIV infection and CD4 count 400 cellsmm3
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators while IFN alfa-2a inhibits translation of viral proteins Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators while IFN alfa-2a inhibits translation of viral proteins Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects
Detailed Description:
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators while IFN alfa-2a inhibits translation of viral proteins Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects
Patients are randomly assigned to one of three treatment arms to receive AZTddC alone or combined with one of two doses of IFN alfa-2a Treatment continues for up to 12 months after enrollment of the last patient Patients are followed at 2 4 and 8 weeks and every 8 weeks thereafter Mean duration of follow-up is expected to be 13 months
Patients are randomly assigned to one of three treatment arms to receive AZTddC alone or combined with one of two doses of IFN alfa-2a Treatment continues for up to 12 months after enrollment of the last patient Patients are followed at 2 4 and 8 weeks and every 8 weeks thereafter Mean duration of follow-up is expected to be 13 months
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 |
|---|---|---|---|
| 11173 | REGISTRY | DAIDS ES Registry Number | None |