Comorbidity and Aging With HIV (agehIV)

This study is currently recruiting participants.
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

October 31, 2011
November 4, 2011
October 2010
January 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01466582 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Comorbidity and Aging With HIV
Comorbidity and Aging With HIV, the agehIV Cohort Study

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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.

  • HIV-1-infection
  • Comorbidity
  • Ageing
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1400
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
45 Years and older
Yes
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
Netherlands
 
NCT01466582
NL30802.018.09
No
Prof. dr. Peter Reiss, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Public Health Service of Amsterdam
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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP