Comorbidity and Aging With HIV

NCT01466582 | Active Not Recruiting

• 1 other identifier: NL30802.018.09
• Study Type: observational
• Target: 1,148
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV-1-infection; Comorbidity; Ageing

Keywords

HIV-1-infection; comorbidity; ageing

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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.

Secondary Outcomes (2)

• Quality of life measured using the Medical Outcomes Study Short Form 36-item health survey (SF-36)

  At baseline and after 2 years

• Management strategies

  After 4 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Public Health Service of Amsterdam: collaborator

Study Sites (2)

Public Health Service Amsterdam

Amsterdam, 1018WT, Netherlands

Location

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

Related Publications (26)

• Kooij KW, Vogt L, Wit FWNM, van der Valk M, van Zoest RA, Goorhuis A, Prins M, Post FA, Reiss P; AGEhIV Cohort Study. Higher Prevalence and Faster Progression of Chronic Kidney Disease in Human Immunodeficiency Virus-Infected Middle-Aged Individuals Compared With Human Immunodeficiency Virus-Uninfected Controls. J Infect Dis. 2017 Sep 15;216(6):622-631. doi: 10.1093/infdis/jix202.

  PMID: 28934420 BACKGROUND

• van Zoest RA, van der Valk M, Wit FW, Vaartjes I, Kooij KW, Hovius JW, Prins M, Reiss P; AGEhIV Cohort Study Group. Suboptimal primary and secondary cardiovascular disease prevention in HIV-positive individuals on antiretroviral therapy. Eur J Prev Cardiol. 2017 Aug;24(12):1297-1307. doi: 10.1177/2047487317714350. Epub 2017 Jun 5.

  PMID: 28578613 BACKGROUND

• Langebeek N, Kooij KW, Wit FW, Stolte IG, Sprangers MAG, Reiss P, Nieuwkerk PT; AGEhIV Cohort Study Group. Impact of comorbidity and ageing on health-related quality of life in HIV-positive and HIV-negative individuals. AIDS. 2017 Jun 19;31(10):1471-1481. doi: 10.1097/QAD.0000000000001511.

  PMID: 28574965 BACKGROUND

• Su T, Mutsaerts HJ, Caan MW, Wit FW, Schouten J, Geurtsen GJ, Sharp DJ, Prins M, Richard E, Portegies P, Reiss P, Majoie CB; AGEhIV Cohort Study. Cerebral blood flow and cognitive function in HIV-infected men with sustained suppressed viremia on combination antiretroviral therapy. AIDS. 2017 Mar 27;31(6):847-856. doi: 10.1097/QAD.0000000000001414.

  PMID: 28121708 BACKGROUND

• Kooij KW, Wit FW, Booiman T, van der Valk M, Schim van der Loeff MF, Kootstra NA, Reiss P; AGEhIV Cohort Study Group. Cigarette Smoking and Inflammation, Monocyte Activation, and Coagulation in HIV-Infected Individuals Receiving Antiretroviral Therapy, Compared With Uninfected Individuals. J Infect Dis. 2016 Dec 15;214(12):1817-1821. doi: 10.1093/infdis/jiw459. Epub 2016 Sep 28.

  PMID: 27683822 BACKGROUND

• Kooij KW, Schouten J, Wit FW, van der Valk M, Kootstra NA, Stolte IG, van der Meer JT, Prins M, Grobbee DE, van den Born BJ, Reiss P. Difference in Aortic Stiffness Between Treated Middle-Aged HIV Type 1-Infected and Uninfected Individuals Largely Explained by Traditional Cardiovascular Risk Factors, With an Additional Contribution of Prior Advanced Immunodeficiency. J Acquir Immune Defic Syndr. 2016 Sep 1;73(1):55-62. doi: 10.1097/QAI.0000000000001024.

  PMID: 27513572 BACKGROUND

• Su T, Wit FW, Caan MW, Schouten J, Prins M, Geurtsen GJ, Cole JH, Sharp DJ, Richard E, Reneman L, Portegies P, Reiss P, Majoie CB; AGEhIV Cohort Study. White matter hyperintensities in relation to cognition in HIV-infected men with sustained suppressed viral load on combination antiretroviral therapy. AIDS. 2016 Sep 24;30(15):2329-39. doi: 10.1097/QAD.0000000000001133.

  PMID: 27149087 BACKGROUND

• van Zoest RA, Wit FW, Kooij KW, van der Valk M, Schouten J, Kootstra NA, Wiersinga WJ, Prins M, van den Born BJ, Reiss P; AGEhIV Cohort Study Group. Higher Prevalence of Hypertension in HIV-1-Infected Patients on Combination Antiretroviral Therapy Is Associated With Changes in Body Composition and Prior Stavudine Exposure. Clin Infect Dis. 2016 Jul 15;63(2):205-13. doi: 10.1093/cid/ciw285. Epub 2016 May 3.

  PMID: 27143668 BACKGROUND

• Kooij KW, Wit FW, van Zoest RA, Schouten J, Kootstra NA, van Vugt M, Prins M, Reiss P, van der Valk M; AGEhIV Cohort Study Group. Liver fibrosis in HIV-infected individuals on long-term antiretroviral therapy: associated with immune activation, immunodeficiency and prior use of didanosine. AIDS. 2016 Jul 17;30(11):1771-80. doi: 10.1097/QAD.0000000000001119.

  PMID: 27088320 BACKGROUND

• Cobos Jimenez V, Wit FW, Joerink M, Maurer I, Harskamp AM, Schouten J, Prins M, van Leeuwen EM, Booiman T, Deeks SG, Reiss P, Kootstra NA; AGEhIV Study Group. T-Cell Activation Independently Associates With Immune Senescence in HIV-Infected Recipients of Long-term Antiretroviral Treatment. J Infect Dis. 2016 Jul 15;214(2):216-25. doi: 10.1093/infdis/jiw146. Epub 2016 Apr 12.

  PMID: 27073222 BACKGROUND

• Demirkaya N, Wit FW, van Den Berg TJ, Kooij KW, Prins M, Schlingemann RO, Abramoff MD, Reiss P, Verbraak FD; AGEhIV Cohort Study Group. HIV-Associated Neuroretinal Disorder in Patients With Well-Suppressed HIV-Infection: A Comparative Cohort Study. Invest Ophthalmol Vis Sci. 2016 Mar;57(3):1388-97. doi: 10.1167/iovs.15-18537.

  PMID: 27018841 BACKGROUND

• Schouten J, Su T, Wit FW, Kootstra NA, Caan MW, Geurtsen GJ, Schmand BA, Stolte IG, Prins M, Majoie CB, Portegies P, Reiss P; AGEhIV Study Group. Determinants of reduced cognitive performance in HIV-1-infected middle-aged men on combination antiretroviral therapy. AIDS. 2016 Apr 24;30(7):1027-38. doi: 10.1097/QAD.0000000000001017.

  PMID: 26752277 BACKGROUND

• Moller LM, Brands R, Sluiter JK, Schouten J, Wit FW, Reiss P, Prins M, Stolte IG. Prevalence and determinants of insufficient work ability in older HIV-positive and HIV-negative workers. Int Arch Occup Environ Health. 2016 May;89(4):699-709. doi: 10.1007/s00420-015-1108-0. Epub 2016 Jan 8.

  PMID: 26747456 BACKGROUND

• Su T, Caan MW, Wit FW, Schouten J, Geurtsen GJ, Cole JH, Sharp DJ, Vos FM, Prins M, Portegies P, Reiss P, Majoie CB; AGEhIV Cohort Study. White matter structure alterations in HIV-1-infected men with sustained suppression of viraemia on treatment. AIDS. 2016 Jan;30(2):311-22. doi: 10.1097/QAD.0000000000000945.

  PMID: 26691551 BACKGROUND

• Kooij KW, Wit FW, Schouten J, van der Valk M, Godfried MH, Stolte IG, Prins M, Falutz J, Reiss P; AGEhIV Cohort Study Group. HIV infection is independently associated with frailty in middle-aged HIV type 1-infected individuals compared with similar but uninfected controls. AIDS. 2016 Jan;30(2):241-50. doi: 10.1097/QAD.0000000000000910.

  PMID: 26684821 BACKGROUND

• Su T, Schouten J, Geurtsen GJ, Wit FW, Stolte IG, Prins M, Portegies P, Caan MW, Reiss P, Majoie CB, Schmand BA; AGEhIV Cohort Study Group. Multivariate normative comparison, a novel method for more reliably detecting cognitive impairment in HIV infection. AIDS. 2015 Mar 13;29(5):547-57. doi: 10.1097/QAD.0000000000000573.

  PMID: 25587908 RESULT

• Schouten J, Wit FW, Stolte IG, Kootstra NA, van der Valk M, Geerlings SE, Prins M, Reiss P; AGEhIV Cohort Study Group. Cross-sectional comparison of the prevalence of age-associated comorbidities and their risk factors between HIV-infected and uninfected individuals: the AGEhIV cohort study. Clin Infect Dis. 2014 Dec 15;59(12):1787-97. doi: 10.1093/cid/ciu701. Epub 2014 Sep 2.

  PMID: 25182245 RESULT

• Kooij KW, Wit FW, Bisschop PH, Schouten J, Stolte IG, Prins M, van der Valk M, Prins JM, van Eck-Smit BL, Lips P, Reiss P; AGEhIV Cohort Study group. Low bone mineral density in patients with well-suppressed HIV infection: association with body weight, smoking, and prior advanced HIV disease. J Infect Dis. 2015 Feb 15;211(4):539-48. doi: 10.1093/infdis/jiu499. Epub 2014 Sep 1.

  PMID: 25180239 RESULT

• Vanbellinghen MC, Boyd A, Kootstra NA, Schim van der Loeff MF, van der Valk M, Reiss P; AGEhIV Cohort study group. A Biomarker Profile Reflective of Preserved Thymic Function Is Associated With Reduced Comorbidities in Aging People With HIV: An AGEhIV Cohort Analysis. J Infect Dis. 2025 Mar 17;231(3):622-632. doi: 10.1093/infdis/jiae603.

  PMID: 39658325 DERIVED

• Verburgh ML, Boyd A, Schim van der Loeff MF, Bakker M, Wit FWNM, van der Valk M, Grobben M, van Pul L, Tejjani K, van Rijswijk J, van Gils MJ, Kootstra NA, van der Hoek L, Reiss P; AGEhIV Cohort Study. Similar Limited Protection Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron Infection in Vaccinated Individuals With HIV and Comparable Controls. Open Forum Infect Dis. 2024 Jul 8;11(7):ofae380. doi: 10.1093/ofid/ofae380. eCollection 2024 Jul.

  PMID: 39070044 DERIVED

• Verburgh ML, van der Valk M, Rijnders BJA, Reiss P, Wit FWNM. No association between use of tenofovir disoproxil fumarate, etravirine, or integrase-strand transfer inhibitors and acquisition or severe outcomes of SARS-CoV-2 infection in people with HIV in the Netherlands. AIDS. 2023 Jul 15;37(9):1481-1486. doi: 10.1097/QAD.0000000000003577. Epub 2023 Apr 13.

  PMID: 37395254 DERIVED

• Schaaf REA, Verburgh ML, Boyd A, Wit FW, Nieuwkerk PT, Schim van der Loeff MF, Reiss P; AGEhIV Study Group. Change in Substance Use and the Effects of Social Distancing on Health-Related Quality of Life and Depressive Symptoms During the COVID-19 Pandemic in People Living With and Without HIV. J Acquir Immune Defic Syndr. 2022 Nov 1;91(3):261-268. doi: 10.1097/QAI.0000000000003055. Epub 2022 Jul 13.

  PMID: 36252241 DERIVED

• Verboeket SO, Boyd A, Wit FW, Verheij E, Schim van der Loeff MF, Kootstra N, van der Valk M, van Steenwijk RP, Drummond MB, Kirk GD, Reiss P; AGEhIV Cohort Study. Changes in lung function among treated HIV-positive and HIV-negative individuals: analysis of the prospective AGEhIV cohort study. Lancet Healthy Longev. 2021 Apr;2(4):e202-e211. doi: 10.1016/S2666-7568(21)00033-7.

  PMID: 36098121 DERIVED

• Verburgh ML, Boyd A, Wit FWNM, Schim van der Loeff MF, van der Valk M, Bakker M, Kootstra NA, van der Hoek L, Reiss P. Similar Risk of Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Similar Nucleocapsid Antibody Levels in People With Well-Controlled Human Immunodeficiency Virus (HIV) and a Comparable Cohort of People Without HIV. J Infect Dis. 2022 Jun 1;225(11):1937-1947. doi: 10.1093/infdis/jiab616.

  PMID: 34929034 DERIVED

• Verheij E, Kirk GD, Wit FW, van Zoest RA, Verboeket SO, Lemkes BA, Schim van der Loeff MF, Reiss P; AGEhIV Cohort. Frailty Is Associated With Mortality and Incident Comorbidity Among Middle-Aged Human Immunodeficiency Virus (HIV)-Positive and HIV-Negative Participants. J Infect Dis. 2020 Aug 17;222(6):919-928. doi: 10.1093/infdis/jiaa010.

  PMID: 31956893 DERIVED

• Verboeket SO, Wit FW, Kirk GD, Drummond MB, van Steenwijk RP, van Zoest RA, Nellen JF, Schim van der Loeff MF, Reiss P; AGEhIV Study Group. Reduced Forced Vital Capacity Among Human Immunodeficiency Virus-Infected Middle-Aged Individuals. J Infect Dis. 2019 Apr 8;219(8):1274-1284. doi: 10.1093/infdis/jiy653.

  PMID: 30418599 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum (EDTA/heparin/citrate), PBMCs, urine, stool (for future microbiome studies)

Study Officials

• Peter Reiss, MD, PhD

  Amsterdam University Medical Centers, University of Amsterdam, Amsterdam; Amsterdam Institute for Global Health and Development, Amsterdam

  PRINCIPAL INVESTIGATOR

• Maria Prins, PhD

  Public Health Service Amsterdam, Amsterdam; Academic Medical Center, Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 8, 2011
• Study Start: October 1, 2010
• Primary Completion (Estimated): October 1, 2040
• Study Completion (Estimated): October 1, 2040
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

NL (2)