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Comorbidity and Aging With HIV (agehIV)

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ClinicalTrials.gov Identifier: NCT01466582
Recruitment Status : Active, not recruiting
First Posted : November 8, 2011
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Public Health Service of Amsterdam
Information provided by (Responsible Party):
Prof. dr. Peter Reiss, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
HIV-1-infection Comorbidity Ageing

Detailed Description:

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 Design
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Study Type : Observational
Actual Enrollment : 1148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comorbidity and Aging With HIV, the agehIV Cohort Study
Study Start Date : October 2010
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
HIV-negative controls
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.
HIV-positive patients
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.


Outcome Measures
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Primary Outcome Measures :
  1. The prevalence of comorbidities, organ system dysfunction and their risk factors at time of enrolment [ Time Frame: at enrolment and after 2 years follow up ]
    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

  2. The incidence of comorbidities, organ system dysfunction and their risk factors after two years of follow up [ Time Frame: After 2 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


Secondary Outcome Measures :
  1. Quality of life [ 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.

  2. 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
whole blood, serum (EDTA/heparin/citrate), PBMCs, urine

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • For the HIV-positive patients: HIV-1 infection and aged 45 years and above
  • For the HIV-negative controls: HIV-uninfected and aged 45 years and above

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Netherlands
Public Health Service Amsterdam
Amsterdam, Netherlands, 1018WT
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Public Health Service of Amsterdam
Investigators
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
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: Prof. dr. Peter Reiss, Clinical Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01466582     History of Changes
Other Study ID Numbers: NL30802.018.09
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Prof. dr. Peter Reiss, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
HIV-1-infection
comorbidity
ageing