Aging, PrematureVIHVANCT06554210
Epidemiological Study of the Markers of Aging in the Cohort of Patient HIV in Brest
An observational study of Aging, Premature and HIV Infections, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aging, Premature, HIV Infections
- How many people
- 213 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2017to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All persons followed between 2003 to 2018 in the one center (Internal Médicine) of the West Brittany cohort
Who may be able to join
- HIV positive persons followed in Internal Medicine departement of Brest University Hospital
Who cannot join
- opposition of the study
- <18 ans
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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, age>18 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
Read the 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
- 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
- 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
- Correlate aging data of each organ with determinants, correlate between organs with and without adjustment to determinants
- 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.
- Conditions
- Aging, Premature, HIV Infections
- Keywords
- Aging, HIV
- Medical subject headings
- Aging, Premature, HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
renal aging
creatinin level, creatinin clearance, microalbuminuria
Measured: yearly
pulmonary aging
respiratory functional test
Measured: at last one
liver aging
elastometry (Fibroscan*)
Measured: at last one
neurological aging
memory tests
Measured: at last one
vascular aging
intima-media thickness, systolic and diastolic blood pressure
Measured: at last one
Bone aging
osteodensitometry
Measured: at last one
heart aging
ECG, echography
Measured: at last one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start8 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging, PrematureStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc de Saint-Martin, MD, PhD, Study director, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554210
- Sponsor's protocol ID
- VIHVA 2016.CE31
- Acronym
- VIHVA
- Status last verified
- Aug 2024
- First submitted
- 1 Oct 2018
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of the Markers of Aging in the Cohort of Patient HIV in Brest
- ClinicalTrials.gov ID
- NCT06554210
- Acronym / sponsor ID
- VIHVA / VIHVA 2016.CE31
- Conditions
- Aging, Premature, HIV Infections
- Keywords
- Aging, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, age>18 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
- 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
- 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
- Correlate aging data of each organ with determinants, correlate between organs with and without adjustment to determinants
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All persons followed between 2003 to 2018 in the one center (Internal Médicine) of the West Brittany cohort
Key inclusion criteria (1 listed)
- HIV positive persons followed in Internal Medicine departement of Brest University Hospital
Key exclusion criteria (2 listed)
- opposition of the study
- <18 ans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
renal aging
Time frame: yearly
creatinin level, creatinin clearance, microalbuminuria
pulmonary aging
Time frame: at last one
respiratory functional test
liver aging
Time frame: at last one
elastometry (Fibroscan*)
neurological aging
Time frame: at last one
memory tests
vascular aging
Time frame: at last one
intima-media thickness, systolic and diastolic blood pressure
Bone aging
Time frame: at last one
osteodensitometry
heart aging
Time frame: at last one
ECG, echography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc de Saint-Martin, MD, PhD study director
University Hospital, Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, Premature and HIV Infections, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal aging (time frame: yearly). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.