Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125814
Status:
TERMINATED
Last Update Posted:
2005-08-16
First Post:
2005-08-01
Brief Title:
Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Multi-Center Trial to Evaluate the Efficacy and Safety of Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression ANRS 105 INTERVAC
Status:
TERMINATED
Status Verified Date:
2005-08
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 determine whether the adjunctional of interferon alfa to structured treatment interruptions correlated with a long time off treatment in HIV-1 infection
Detailed Description:
The limitations of the drugs used against HIV include their toxicity their tolerability their propensity to induce resistance when not taken with absolute regularity and their cost Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection is associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart In patients with high CD4 cell counts patients receiving treatment of chronic infection with controlled viremia and patients who are receiving highly active antiretroviral therapy HAART now in whom treatment would not have been started based on current guidelines the investigators evaluated whether the adjunctional of interferon alfa 2b to 3 structured treatment interruptions correlated with a long time off treatment HAART was interrupted for 4 weeks restarted and continued for 12 weeks After 3 such cycles treatment was indefinitely suspended 48 weeks after study entry Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption proviral HIV DNA at baseline and during follow-up plasma HIV RNA at baseline and during follow-up CD4 T cell and CD8 T cell HIV specific responses at baseline and after 6 months of interruption
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