Comorbidity and Aging With HIV (agehIV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01466582|
Recruitment Status : Active, not recruiting
First Posted : November 8, 2011
Last Update Posted : January 13, 2020
|Condition or disease|
|HIV-1-infection Comorbidity Ageing|
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.
|Study Type :||Observational|
|Actual Enrollment :||1148 participants|
|Official Title:||Comorbidity and Aging With HIV, the agehIV Cohort Study|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2024|
|Estimated Study Completion Date :||October 2024|
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 [ 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. ]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
- The incidence of comorbidities, organ system dysfunction and their risk factors after two years of follow up [ 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. ]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
- Quality of life measured using the Medical Outcomes Study Short Form 36-item health survey (SF-36) [ Time Frame: At baseline and after 2 years ]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.
- Management strategies [ Time Frame: After 4 years ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466582
|Public Health Service Amsterdam|
|Amsterdam, Netherlands, 1018WT|
|Academic Medical Center|
|Amsterdam, Netherlands, 1105AZ|
|Principal Investigator:||Peter Reiss, MD, PhD||Academic Medical Center, Amsterdam; Amsterdam Institute for Global Health and Development, Amsterdam|
|Principal Investigator:||Maria Prins, PhD||Public Health Service Amsterdam, Amsterdam; Academic Medical Center, Amsterdam|