Ignite Creation Date:
2024-05-05 @ 11:16 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01296373
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2011-02-13
Brief Title:
A Study to Explore Reconstitution of Immunity in Patients With Advanced HIV-1-infection
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official Title:
An Observational Study to Explore Reconstitution of Immunity in Patients With Advanced HIV-1-infection Commencing Combination Antiretroviral Therapy HIVNAT 136 RESTORE StudyThailand
Status:
COMPLETED
Status Verified Date:
2013-12
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:
RESTORE
Brief Summary:
RESTORE studyThailand is a prospective observational study of HIV-1-infected patients who are either treatment naïve or who have been off anti-retroviral therapy for a 12 months who have a CD4 T cell count less than or equal to 350 cellsµL and who have been deemed by their treating physician that commencement of combination antiretroviral therapy cART which is expected to reduce plasma HIV RNA by 1log10 copiesmL is necessary
The primary intent of this protocol is to prospectively establish a cohort of patients from whom clinical data and peripheral blood samples serum plasma and peripheral blood mononuclear cells can be stored for substudies examining reconstitution of the immune system and its relationship to disease outcomes
The primary intent of this protocol is to prospectively establish a cohort of patients from whom clinical data and peripheral blood samples serum plasma and peripheral blood mononuclear cells can be stored for substudies examining reconstitution of the immune system and its relationship to disease outcomes
Detailed Description:
RESTORE studyThailand is a prospective observational study of HIV-1-infected patients who are either treatment naïve or who have been off anti-retroviral therapy for a 12 months who have a CD4 T cell count less than or equal to 350 cellsµL and who have been deemed by their treating physician that commencement of combination antiretroviral therapy cART which is expected to reduce plasma HIV RNA by 1log10 copiesmL is necessary
The primary intent of this protocol is to prospectively establish a cohort of patients from whom clinical data and peripheral blood samples serum plasma and peripheral blood mononuclear cells can be stored for substudies examining reconstitution of the immune system and its relationship to disease outcomes
Patients who have recently had an opportunistic infection OI can also be enrolled Investigators should consider the results of the ACTG A5164 1 SAPIT 2 and Makadzange and colleagues 3 studies in regard to the timing of cART introduction following the acute OI This observational protocol does not stipulate the timing of cART introduction but cART should not normally be delayed beyond 2 months after the diagnosis of an acute OI
Patients will be commenced on cART regimens as determined by the treating physician Patients will be observed and pertinent clinical data will be recorded at visits that will coincide with their standard of care visits The visit schedule in year 1 is as follows screeningbaseline cART is commenced week 4 8 12 24 and 48 In year 2 and 3 visits are every 6 months In those who in the opinion of the investigator develop a major clinical manifestation of immune restoration disease IRD an extra visit IRD baseline will be conducted If the patient is in the first 12 weeks of study follow-up this is the only additional visit required If however the major IRD event occurs after the week 12 visit in year 1 or in years 2 and 3 in addition to the IRD baseline visit a second additional visit will be conducted 4 weeks later It is likely that these extra visits would be required for the management of their clinical disease Details pertaining to the cause course and treatment of the IRD event will be recorded These will include clinical data and pathology results Prior to starting cART and at each study visit extra blood samples will be taken for storage and subsequent analysis It is envisaged that these storage samples will be used for subsequent exploration of aspects of immunity including but not limited to pathogen specific immune responses including pathogen load anti-HIV immunity pathogen specific and other clinical syndromes associated with immune reconstitution B-cell responses immune activation and HIV viral dynamics A sample for genetic testing will be obtained at baseline The rationale for this is to determine host genetic polymorphisms that may predict immune reconstitution with cART andor predispose to the development of IRD Patients will be followed for 3 years
The primary intent of this protocol is to prospectively establish a cohort of patients from whom clinical data and peripheral blood samples serum plasma and peripheral blood mononuclear cells can be stored for substudies examining reconstitution of the immune system and its relationship to disease outcomes
Patients who have recently had an opportunistic infection OI can also be enrolled Investigators should consider the results of the ACTG A5164 1 SAPIT 2 and Makadzange and colleagues 3 studies in regard to the timing of cART introduction following the acute OI This observational protocol does not stipulate the timing of cART introduction but cART should not normally be delayed beyond 2 months after the diagnosis of an acute OI
Patients will be commenced on cART regimens as determined by the treating physician Patients will be observed and pertinent clinical data will be recorded at visits that will coincide with their standard of care visits The visit schedule in year 1 is as follows screeningbaseline cART is commenced week 4 8 12 24 and 48 In year 2 and 3 visits are every 6 months In those who in the opinion of the investigator develop a major clinical manifestation of immune restoration disease IRD an extra visit IRD baseline will be conducted If the patient is in the first 12 weeks of study follow-up this is the only additional visit required If however the major IRD event occurs after the week 12 visit in year 1 or in years 2 and 3 in addition to the IRD baseline visit a second additional visit will be conducted 4 weeks later It is likely that these extra visits would be required for the management of their clinical disease Details pertaining to the cause course and treatment of the IRD event will be recorded These will include clinical data and pathology results Prior to starting cART and at each study visit extra blood samples will be taken for storage and subsequent analysis It is envisaged that these storage samples will be used for subsequent exploration of aspects of immunity including but not limited to pathogen specific immune responses including pathogen load anti-HIV immunity pathogen specific and other clinical syndromes associated with immune reconstitution B-cell responses immune activation and HIV viral dynamics A sample for genetic testing will be obtained at baseline The rationale for this is to determine host genetic polymorphisms that may predict immune reconstitution with cART andor predispose to the development of IRD Patients will be followed for 3 years
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