Ignite Creation Date:
2024-05-06 @ 10:11 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03198325
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2017-06-21
Brief Title:
Monitored Antiretroviral Pause in Chronic HIV-Infected Subjects With Long-Lasting Suppressed Viremia
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Monitored Antiretroviral Pause in Chronic HIV-Infected Subjects With Long-Lasting Suppressed Viremia APACHE Study
Status:
COMPLETED
Status Verified Date:
2024-02
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:
APACHE
Brief Summary:
Prospective open-label single arm non-randomized proof-of-concept study Eligible patients will sign a written informed consent and will be followed-up at screening baseline ART interruption and at 1 2 3 4 6 8 10 12 16 24 32 40 48 weeks thereafter or at ART resumption
The study visits will include general clinical assessment routine laboratory tests including creatinine phosphorus calcium alkaline phosphatase AST ALT fasting glucose total cholesterol HDL- and LDL-cholesterol triglycerides CD4 cell count and CD4CD8 ratio
Additional 30 mL of peripheral blood will be withdrawn at study visits for further virological and immunological investigations and for bio-banking purposes
During follow-up the occurrence of two consecutive HIV-1 RNA values 50 copiesmL or the occurrence of stage B or C AIDS-defining events or any serious non-AIDS clinical event at least potentially related to treatment interruption will be criteria for ART resumption
All patients with HIV-RNA50 copiesmL at week 48 end of the study will resume their baseline ART regimen
The main demographic clinical and therapy information will be accurately recorded at the study visits in an electronic Case Report Form
The study visits will include general clinical assessment routine laboratory tests including creatinine phosphorus calcium alkaline phosphatase AST ALT fasting glucose total cholesterol HDL- and LDL-cholesterol triglycerides CD4 cell count and CD4CD8 ratio
Additional 30 mL of peripheral blood will be withdrawn at study visits for further virological and immunological investigations and for bio-banking purposes
During follow-up the occurrence of two consecutive HIV-1 RNA values 50 copiesmL or the occurrence of stage B or C AIDS-defining events or any serious non-AIDS clinical event at least potentially related to treatment interruption will be criteria for ART resumption
All patients with HIV-RNA50 copiesmL at week 48 end of the study will resume their baseline ART regimen
The main demographic clinical and therapy information will be accurately recorded at the study visits in an electronic Case Report Form
Detailed Description:
The aim of this proof-of-concept study on adult 18 and 65 years old chronically HIV-1 infected individuals with undetectable viremia for 10 years undetectable HIV-DNA CD4500 cellsµL and no evidence of detectable residual viremia for 5 years is to evaluate the frequency of spontaneous control of virus replication after ART pausing for up to 12 months and to identify the virological and immunological markers associated with spontaneous control of viral replication
Prospective open-label single arm non-randomized proof-of-concept study
Eligible patients will sign a written informed consent and will be followed-up at screening baseline ART interruption and at 1 2 3 4 6 8 10 12 16 24 32 40 48 weeks thereafter or at ART resumption
The clinical assessment study visit will include the evaluation of CDC stage height weight systolic and diastolic blood pressure and smoking status routine laboratory tests including creatinine phosphorus calcium alkaline phosphatase AST ALT fasting glucose total cholesterol HDL- and LDL-cholesterol triglycerides CD4 cell count and CD4CD8 ratio urine analysis
Additional 30 mL of peripheral blood will be withdrawn at study visits and stored in a biobank for further investigations
During follow-up the occurrence of two consecutive HIV-1 RNA values 50 copiesmL or the occurrence of stage B or C AIDS-defining events will be criteria for ART resumption or any serious non-AIDS clinical event at least potentially related to treatment interruption
All patients with HIV-RNA50 copiesmL at week 48 end of the study will resume their baseline ART regimen
The main demographic clinical and therapy information will be accurately recorded at the study visits in an electronic Case Report Form eCRF
Prospective open-label single arm non-randomized proof-of-concept study
Eligible patients will sign a written informed consent and will be followed-up at screening baseline ART interruption and at 1 2 3 4 6 8 10 12 16 24 32 40 48 weeks thereafter or at ART resumption
The clinical assessment study visit will include the evaluation of CDC stage height weight systolic and diastolic blood pressure and smoking status routine laboratory tests including creatinine phosphorus calcium alkaline phosphatase AST ALT fasting glucose total cholesterol HDL- and LDL-cholesterol triglycerides CD4 cell count and CD4CD8 ratio urine analysis
Additional 30 mL of peripheral blood will be withdrawn at study visits and stored in a biobank for further investigations
During follow-up the occurrence of two consecutive HIV-1 RNA values 50 copiesmL or the occurrence of stage B or C AIDS-defining events will be criteria for ART resumption or any serious non-AIDS clinical event at least potentially related to treatment interruption
All patients with HIV-RNA50 copiesmL at week 48 end of the study will resume their baseline ART regimen
The main demographic clinical and therapy information will be accurately recorded at the study visits in an electronic Case Report Form eCRF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None