Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188851
Status:
COMPLETED
Last Update Posted:
2005-09-16
First Post:
2005-09-12
Brief Title:
Structured Treatment Interruption for HIV Patients With Virologic Failure
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Prospective Randomized Trial of Structured Treatment InterruptionSTI Followed by Initiation of a New Antiretroviral RegimenARV Versus Immediate Switching to a New ARV in HIV-Infected Patients Experiencing Virologic Failure on HAART
Status:
COMPLETED
Status Verified Date:
2005-09
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:
The purpose of this study is to assess the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch
Hypothesis A STI prior to starting a salvage regimen will result in an improved virologic response
Hypothesis A STI prior to starting a salvage regimen will result in an improved virologic response
Detailed Description:
To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch
Hypothesis By withdrawing ARV drug pressure resistant HIV virus will revert to wild-type In treatment-experienced HIV patients who experience virologic failure a STI prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime
Interventions
Immediate Switch to Salvage Therapy Patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results
Structured Treatment Interruption Patients randomized to the STI arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week A salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results
Hypothesis By withdrawing ARV drug pressure resistant HIV virus will revert to wild-type In treatment-experienced HIV patients who experience virologic failure a STI prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime
Interventions
Immediate Switch to Salvage Therapy Patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results
Structured Treatment Interruption Patients randomized to the STI arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week A salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None