Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000831
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
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 elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175 and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy Specifically to determine in patients who have been taking zidovudine AZT alone for a long time whether it is beneficial to add lamivudine 3TC to AZT or to switch to d4T alone and also to determine in patients who have been taking didanosine ddI alone for a long time whether it is beneficial to add AZT or AZT3TC to ddI
Characteristics of virus replication pathogenicity and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical virologic and CD4 cell response compared to continuation of AZT alone
Characteristics of virus replication pathogenicity and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical virologic and CD4 cell response compared to continuation of AZT alone
Detailed Description:
Characteristics of virus replication pathogenicity and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical virologic and CD4 cell response compared to continuation of AZT alone
Patients with prior AZT experience only are randomized to receive either d4T alone or AZT3TC Patients with prior ddI experience only are randomized to receive ddIAZT or ddIAZT3TC PER AMENDMENT 82796 The study has been extended 6 months and treatment will be available until March 15 1997 at the latest Each patient will have regularly scheduled 12 week safety visits during the extension period
AS PER AMENDMENT 12297 The study has been extended for approximately 16 additional weeks beyond the current 6-month extension Subjects will be unblinded to their assigned regimen beginning 22197 and will continue therapy for up to 16 weeks in open-label fashion AS PER AMENDMENT 5997 The study has been extended for an additional 8 weeks study drug will not be provided after 91597
Patients with prior AZT experience only are randomized to receive either d4T alone or AZT3TC Patients with prior ddI experience only are randomized to receive ddIAZT or ddIAZT3TC PER AMENDMENT 82796 The study has been extended 6 months and treatment will be available until March 15 1997 at the latest Each patient will have regularly scheduled 12 week safety visits during the extension period
AS PER AMENDMENT 12297 The study has been extended for approximately 16 additional weeks beyond the current 6-month extension Subjects will be unblinded to their assigned regimen beginning 22197 and will continue therapy for up to 16 weeks in open-label fashion AS PER AMENDMENT 5997 The study has been extended for an additional 8 weeks study drug will not be provided after 91597
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 |
|---|---|---|---|
| 11277 | REGISTRY | DAIDS ES Registry Number | None |