An observational study in HIV-1-infection, Comorbidity and Ageing, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Active, not recruiting at 2 sites in Netherlands. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
In this prospective cohort study the investigators will assess the prevalence and incidence of a broad range of age-related co-morbidities and their (known) risk factor among HIV-patients and HIV-negative controls. HIV might cause premature onset or accelerated aging and could therefore result in an increase of age-related comorbidities when compared with controls.
The standard use of combination antiretroviral therapy (cART) has resulted in major and sustained declines in HIV-associated morbidity and mortality. Nonetheless, the life expectancy of patients with HIV on cART still remains 10 or more years shorter than that of uninfected persons of the same age, especially in patients starting cART at the time infection is already advanced. A greater risk of a broad range of co-morbidities, experienced by as many as 60% of patients, even after adjustment for age, may contribute to this discrepancy. Several studies have demonstrated an increased incidence of heart disease, diabetes mellitus, kidney disease, liver disease, osteoporosis, malignancies (other than Kaposi's sarcoma and non-Hodgkin's lymphoma traditionally associated with HIV), cognitive disorders and possibly chronic obstructive pulmonary disease in HIV-infected individuals when compared to age matched HIV-uninfected controls. Of note, the incidence of each of the mentioned co-morbidities is also higher after adjustment for age and other traditional risk factors. Most studies were conducted in the United States where prevalence of and risk factors for the various co-morbidities may be different than in Europe, in particular the Netherlands.
HIV-related factors and adverse effects of cART each may independently contribute to the observed increased risk of several of the earlier mentioned co-morbidities. Interestingly, HIV-infected men in the absence of cART have increased frailty (a clinical syndrome associated with aging that identifies a subset of older adults at high risk of mortality and other adverse outcomes) when compared to uninfected men of similar age. Middle aged HIV-infected men despite cART use also show reduction in exercise capacity, functional performance, physical activity, and grip strength.
The multidisciplinary expertise regarding co-morbidities which is present within the AMC in close collaboration with the existing data collection structures of the HIV Monitoring Foundation (HMF) and the Cluster of Infectious Diseases of the Public Health Service Amsterdam (PHSA), offers a unique opportunity to systematically identify the burden of co-morbidity, their (known) risk factors and their effect on quality of life among HIV-infected individuals and in a comparable group of uninfected individuals.
As of August 2020, the study was amended to include a substudy, the main aim of which is to determine and compare the rate of SARS-CoV-2 infection, the extent of the SARS-CoV-2-specific adaptive immune response, and the incidence and severity of COVID-19 disease between PWH and HIV-negative cohort participants who remain in active follow-up.
Furthermore, if disease prevalence is sufficiently high, another aim will be to determine and compare risk factors for the development of severe COVID-19 between PWH and HIV-negative controls. Furthermore, an attempt will be made to compare the impact of nationally imposed social distancing measures on substance use, medication adherence, sexual behavior, quality of life and depressive symptoms in study participants.
Specific aims
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,148 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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The HIV-positive patients are recruited at the HIV outpatient clinic of the Academic Medical Center The HIV-negative controls are recruited at the STD-clinic of the Public Health Service Amsterdam and at the existing Amsterdam Cohort Studies.
Exclusion Criteria:
A group of HIV-negative controls, aged 45 years and above, that is recruited at the STD-clinic of the Public Health Service Amsterdam or at the existing Amsterdam Cohort Studies.
A group of HIV-1-infected patients, aged 45 years and above, that is recruited at the HIV outpatient clinic of the Academic Medical Center.
The prevalence of comorbidities, organ system dysfunction and their risk factors at time of enrolment
To assess the prevalence and incidence of comorbidities, organ system dysfunction and their risk factors over two years of follow-up in a cohort of HIV-infected individuals (mostly on antiretroviral therapy) and in a cohort of comparable but uninfected controls
Time frame: at enrolment and after every 2 years follow up. The Ethics Committee has approved for the study to continue without a set end-date, depending on continued funding.
The incidence of comorbidities, organ system dysfunction and their risk factors after two years of follow up
To assess the incidence of comorbidities, organ system dysfunction and their risk factors after tow years of follow up in a cohort of HIV-infected individuals (mostly on antiretroviral therapy) in comparison to that of a cohort of comparable but uninfected controls
Time frame: After every 2 years of follow up.The Ethics Committee has approved for the study to continue without a set end-date, depending on continued funding.
Quality of life measured using the Medical Outcomes Study Short Form 36-item health survey (SF-36)
To compare quality of life both at baseline and over time, between patients who are HIV-infected or HIV-uninfected, and with and without co-morbidity.
Time frame: At baseline and after 2 years
Management strategies
To suggest appropriate management strategies for identified co-morbidities in the HIV-infected cohort and their risk factors, if advice is requested by the patient's HIV physician. To assess over time if the prevalence and incidence of co-morbidity burden have changed.
Time frame: After 4 years
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)