Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554210
Status:
COMPLETED
Last Update Posted:
None
First Post:
2018-10-01
Brief Title:
Epidemiological Study of the Markers of Aging in the Cohort of Patient HIV in Brest
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Epidemiological Study of the Markers of Aging in the Cohort of Patient HIV in Brest
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIHVA
Brief Summary:
RATIONALE HIV pathology has been associated with accelerated aging of the infected organism with no known knowledge of virus immunosuppression immune response stimulation antiretroviral toxicity and classic risks The data are in good standing from a multicenter cohort with high statistical power but very heterogeneous and not exhaustive A complementary approach by small comprehensive cohorts is desirable
POPULATION CONCERNED HIV-positive persons OBJECTIVE To describe the aging of the physiological functions of people living with HIV
SECONDARY OBJECTIVES Assess the determinants virus HAART Immunity environment Compare to the general population historical comparisons Compare to main body functions MAIN EVALUATION CRITERIA respiratory functional tests memory test IMTc ECG creatininemia cancer Fibroscan bone densitometry
SECONDARY EVALUATION CRITERIA Age sex phototype CD4 lymphocytes count viral load nadir CD4 antiretroviral exposure alcohol tobacco
METHODOLOGY Monocentric retrospective study STATISTICS Frailty model chi2 test test U INCLUSION CRITERIA Seropositive for HIV age18 years Follow-up at least once in the Internal Medicine department between 1995 and 2018 CRITERIA OF EXCLUSION Refusal of the patient or unreachable patient NUMBER OF PATIENTS Between 200 and 300 CALENDAR Duration of inclusions 3 months Duration of participation of the patient 20 years retrospectives Duration of the study 1 year
POPULATION CONCERNED HIV-positive persons OBJECTIVE To describe the aging of the physiological functions of people living with HIV
SECONDARY OBJECTIVES Assess the determinants virus HAART Immunity environment Compare to the general population historical comparisons Compare to main body functions MAIN EVALUATION CRITERIA respiratory functional tests memory test IMTc ECG creatininemia cancer Fibroscan bone densitometry
SECONDARY EVALUATION CRITERIA Age sex phototype CD4 lymphocytes count viral load nadir CD4 antiretroviral exposure alcohol tobacco
METHODOLOGY Monocentric retrospective study STATISTICS Frailty model chi2 test test U INCLUSION CRITERIA Seropositive for HIV age18 years Follow-up at least once in the Internal Medicine department between 1995 and 2018 CRITERIA OF EXCLUSION Refusal of the patient or unreachable patient NUMBER OF PATIENTS Between 200 and 300 CALENDAR Duration of inclusions 3 months Duration of participation of the patient 20 years retrospectives Duration of the study 1 year
Detailed Description:
Rational
HIV pathology has been associated with an accelerated aging of the infected organism without anyone knowing how to do it
the direct toxicity of the virus
CD4 immuno-depletion and its corollary of opportunistic infections modification of microbiota
Reactive immune stimulation with chronic inflammation
the toxicity of antiretrovirals particularly nucleoside analogues responsible for acquired mitochondrial cytopathy
And finally specific environmental factors related to either the mode of acquisition of the infection transfusion drug addiction or the frailty induced by the pathology psychic or social
The discordant data of the great cohorts must be supported by cohorts of smaller sizes more exhaustive both in item and data more homogeneous in their social determinants
Population and Methods
This retrospective monocentric epidemiological study has several objectives
Description of the aging of the population followed on several organs
Comparison with the data of the closest general population geographically sociologically and temporally
Comparison of the relative age of the different organs with each other synchronous aging or not
Evaluation of a screening surveillance strategy adapted to local epidemiology
1 Collect aging data from the functions
Kidney creatinine calculated clearance of creatinine microalbuminuria Liver cytolysis cholestasis Fibroscan pulmonary pulmonary function tests Heart ultrasound ECG Brain memory disorder screening test Psychism depression test Musculoskeletal Bone Densitometry Calcium Phosphoremia Vitamin D Vascular carotid intima-media thickness
2 Evaluate the potential determinants
Demographic gender age phototype Viral subtypes time to infection undetectable delay viral load zenith Immune lymphocyte immunophenotyping nadir CD4 Iatrogen antiretrovirals year patient exposure compliance other treatment Toxic self-administered questionnaire alcohol tobacco and others expired Hb CO gammaGT urinary toxicity test
3 Correlate aging data of each organ with determinants correlate between organs with and without adjustment to determinants
4 Look for the closest population data in the literature and compared with those of the VIHVA cohort
Ethical considerations
The data of VIHVA study approved by the local ethics committee CCPPRB was collected upon obtaining the non-opposition of patients
HIV pathology has been associated with an accelerated aging of the infected organism without anyone knowing how to do it
the direct toxicity of the virus
CD4 immuno-depletion and its corollary of opportunistic infections modification of microbiota
Reactive immune stimulation with chronic inflammation
the toxicity of antiretrovirals particularly nucleoside analogues responsible for acquired mitochondrial cytopathy
And finally specific environmental factors related to either the mode of acquisition of the infection transfusion drug addiction or the frailty induced by the pathology psychic or social
The discordant data of the great cohorts must be supported by cohorts of smaller sizes more exhaustive both in item and data more homogeneous in their social determinants
Population and Methods
This retrospective monocentric epidemiological study has several objectives
Description of the aging of the population followed on several organs
Comparison with the data of the closest general population geographically sociologically and temporally
Comparison of the relative age of the different organs with each other synchronous aging or not
Evaluation of a screening surveillance strategy adapted to local epidemiology
1 Collect aging data from the functions
Kidney creatinine calculated clearance of creatinine microalbuminuria Liver cytolysis cholestasis Fibroscan pulmonary pulmonary function tests Heart ultrasound ECG Brain memory disorder screening test Psychism depression test Musculoskeletal Bone Densitometry Calcium Phosphoremia Vitamin D Vascular carotid intima-media thickness
2 Evaluate the potential determinants
Demographic gender age phototype Viral subtypes time to infection undetectable delay viral load zenith Immune lymphocyte immunophenotyping nadir CD4 Iatrogen antiretrovirals year patient exposure compliance other treatment Toxic self-administered questionnaire alcohol tobacco and others expired Hb CO gammaGT urinary toxicity test
3 Correlate aging data of each organ with determinants correlate between organs with and without adjustment to determinants
4 Look for the closest population data in the literature and compared with those of the VIHVA cohort
Ethical considerations
The data of VIHVA study approved by the local ethics committee CCPPRB was collected upon obtaining the non-opposition of patients
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