Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122551
Status:
TERMINATED
Last Update Posted:
2005-08-01
First Post:
2005-07-19
Brief Title:
Intermittent Therapy in HIV-1 Infected Patients With Successful Viral Suppression Under Highly Active Antiretroviral Therapy HAART
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:
A Prospective Randomized Multicenter Trial of Intermittent Therapy in HIV-Infected Patients With Successful Viral Suppression Under HAART ANRS 106 Window Trial
Status:
TERMINATED
Status Verified Date:
2005-07
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:
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection allowing to achieve undetectable plasma viral RNA restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality long-term toxicity associated with antiretroviral therapy is a real concern The purpose of this study is to compare an intermittent therapy strategy to a continuous treatment in patients with chronic and well controlled HIV-1 infection
Detailed Description:
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection allowing to achieve undetectable plasma viral RNA restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality long-term toxicity associated with antiretroviral therapy is a real concern
The purpose of this study is to compare an intermittent therapy IT strategy 8 weeks off 8 weeks on to a continuous treatment CT in patients with chronic and well controlled HIV-1 infection CD4 over 450µl and plasma HIV1-RNA below 200 cpml under HAART over a 96-week study period
The study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a CD4 cell above 300µl It will compare the proportions of and time to immunological failure CD4 count below 300µl confirmed by a retest 14 days later in the IT and CT groups
The purpose of this study is to compare an intermittent therapy IT strategy 8 weeks off 8 weeks on to a continuous treatment CT in patients with chronic and well controlled HIV-1 infection CD4 over 450µl and plasma HIV1-RNA below 200 cpml under HAART over a 96-week study period
The study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a CD4 cell above 300µl It will compare the proportions of and time to immunological failure CD4 count below 300µl confirmed by a retest 14 days later in the IT and CT groups
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