Comorbidity and Aging With HIV (agehIV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborator:
Public Health Service of Amsterdam
Information provided by (Responsible Party):
Prof. dr. Peter Reiss, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01466582
First received: October 31, 2011
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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
HIV-1-infection
Comorbidity
Ageing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comorbidity and Aging With HIV, the agehIV Cohort Study

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 2 years of follow up ] [ Designated as safety issue: No ]
    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:
  • Quality of life [ Time Frame: At baseline and after 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1400
Study Start Date: October 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466582

Contacts
Contact: Peter Reiss, MD, PhD +31 20 566 3321 p.reiss@amc.nl
Contact: Judith Schouten, MD +31 20 566 9111 j.schouten@amc.nl

Locations
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105AZ
Contact: Peter Reiss, MD, PhD    +31 20 5663321    p.reiss@amc.nl   
Contact: Judith Schouten, MD    +31 20 566 9111 ext 59463    j.schouten@amc.nl   
Principal Investigator: Peter Reiss, MD, PhD         
Sub-Investigator: Judith Schouten, MD         
Sub-Investigator: Ferdinand Wit, MD, PhD         
Sub-Investigator: Marc van der Valk, MD, PhD         
Public Health Service Amsterdam Recruiting
Amsterdam, Netherlands, 1018WT
Contact: Maria Prins, PhD    +31 20 5555 911    mprins@ggd.amsterdam.nl   
Contact: Ineke Stolte, PhD    +31 20 5555 229    istolte@ggd.amsterdam.nl   
Principal Investigator: Maria Prins, PhD         
Sub-Investigator: Ineke Stolte, PhD         
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

No publications provided

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
Study First Received: October 31, 2011
Last Updated: November 4, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
HIV-1-infection
comorbidity
ageing

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014