HIV-1-infectionagehIVNCT01466582
Comorbidity and Aging With HIV
An observational study of HIV-1-infection and Comorbidity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Comorbidity, Ageing
- How many people
- 1,148 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2010to Oct 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Public Health Service Amsterdam
Amsterdam, 1018WT
Academic Medical Center
Amsterdam, 1105AZ
About this study
Official title: 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.
Read the 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.
As of August 2020, the study was amended to include a substudy, the main aim of which is to determine and compare the rate of SARS-CoV-2 infection, the extent of the SARS-CoV-2-specific adaptive immune response, and the incidence and severity of COVID-19 disease between PWH and HIV-negative cohort participants who remain in active follow-up.
Furthermore, if disease prevalence is sufficiently high, another aim will be to determine and compare risk factors for the development of severe COVID-19 between PWH and HIV-negative controls. Furthermore, an attempt will be made to compare the impact of nationally imposed social distancing measures on substance use, medication adherence, sexual behavior, quality of life and depressive symptoms in study participants.
Specific aims
- To assess the SARS-CoV-2 infection rate in HIV-positive and -negative participants over 24 months by combined testing for in vivo SARS-CoV-2 specific antibodies, and in vitro SARS-CoV-2 specific memory B-cell and T-cell responses.
- To assess the course over time of SARS-CoV-2 specific antibody levels, the quantity of SARS-CoV-2-specific memory B-cell, as well as CD4 and CD8 T-cell responses, and the functionality of the overall T cell response in vitro in HIV-positive and -negative participants with demonstrated SARS-CoV-2 infection, as well as the presence of SARS-CoV-2 cross-reactive common cold coronavirus (HKU1, OC43, NL63 and 229E) specific CD4 and CD8 T-cell responses in selected participants.
- To assess the proportion of HIV-positive and -negative participants who carried broadly recognizing coronavirus (HKU1, OC43, NL63 and 229E) antibodies, prior to demonstrated SARS-CoV-2 infection.
- To assess the rate and severity of COVID-19 disease in HIV-positive and -negative participants.
- To assess factors associated with SARS-CoV-2 infection, development of COVID-19 and severe disease (i.e. requiring hospitalization and/or ICU-admission) in HIV-positive and HIV-negative participants.
- To assess associations between nationally imposed social distancing measures and substance use, medication adherence, social behavior, quality of life and depression in study participants.
- Conditions
- HIV-1-infection, Comorbidity, Ageing
- Keywords
- HIV-1-infection, comorbidity, ageing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
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.
Measured: At baseline and after 2 years
Management strategies
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.
Measured: After 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2040 (estimated)
- Study completionOct 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,148 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Service of Amsterdam
- Responsible party
- Principal investigator, Prof. dr. Peter Reiss, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Peter Reiss, MD, PhD, Principal investigator, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam; Amsterdam Institute for Global Health and Development, AmsterdamMaria Prins, PhD, Principal investigator, Public Health Service Amsterdam, Amsterdam; Academic Medical Center, Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466582
- Sponsor's protocol ID
- NL30802.018.09
- Acronym
- agehIV
- Status last verified
- Jul 2024
- First submitted
- 31 Oct 2011
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28934420van 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.
PubMed 28578613Langebeek 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.
PubMed 28574965Su 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.
PubMed 28121708Kooij 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.
PubMed 27683822Kooij 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.
PubMed 27513572Su 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.
PubMed 27149087van 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.
PubMed 27143668Kooij 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.
PubMed 27088320Cobos 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.
PubMed 27073222Demirkaya 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.
PubMed 27018841Schouten 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.
PubMed 26752277Moller 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.
PubMed 26747456Su 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.
PubMed 26691551Kooij 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.
PubMed 26684821
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbidity and Aging With HIV, the agehIV Cohort Study
- ClinicalTrials.gov ID
- NCT01466582
- Acronym / sponsor ID
- agehIV / NL30802.018.09
- Conditions
- HIV-1-infection, Comorbidity, Ageing
- Keywords
- HIV-1-infection, comorbidity, ageing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,148 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Public Health Service of Amsterdam
- Study start
- Oct 2010
- Primary completion
- Oct 2040 (estimated)
- Study completion
- Oct 2040 (estimated)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
As of August 2020, the study was amended to include a substudy, the main aim of which is to determine and compare the rate of SARS-CoV-2 infection, the extent of the SARS-CoV-2-specific adaptive immune response, and the incidence and severity of COVID-19 disease between PWH and HIV-negative cohort participants who remain in active follow-up.
Furthermore, if disease prevalence is sufficiently high, another aim will be to determine and compare risk factors for the development of severe COVID-19 between PWH and HIV-negative controls. Furthermore, an attempt will be made to compare the impact of nationally imposed social distancing measures on substance use, medication adherence, sexual behavior, quality of life and depressive symptoms in study participants.
Specific aims
- To assess the SARS-CoV-2 infection rate in HIV-positive and -negative participants over 24 months by combined testing for in vivo SARS-CoV-2 specific antibodies, and in vitro SARS-CoV-2 specific memory B-cell and T-cell responses.
- To assess the course over time of SARS-CoV-2 specific antibody levels, the quantity of SARS-CoV-2-specific memory B-cell, as well as CD4 and CD8 T-cell responses, and the functionality of the overall T cell response in vitro in HIV-positive and -negative participants with demonstrated SARS-CoV-2 infection, as well as the presence of SARS-CoV-2 cross-reactive common cold coronavirus (HKU1, OC43, NL63 and 229E) specific CD4 and CD8 T-cell responses in selected participants.
- To assess the proportion of HIV-positive and -negative participants who carried broadly recognizing coronavirus (HKU1, OC43, NL63 and 229E) antibodies, prior to demonstrated SARS-CoV-2 infection.
- To assess the rate and severity of COVID-19 disease in HIV-positive and -negative participants.
- To assess factors associated with SARS-CoV-2 infection, development of COVID-19 and severe disease (i.e. requiring hospitalization and/or ICU-admission) in HIV-positive and HIV-negative participants.
- To assess associations between nationally imposed social distancing measures and substance use, medication adherence, social behavior, quality of life and depression in study participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Management strategies
Time frame: After 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 28934420Kooij 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.
- Background: PubMed 28578613van 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.
- Background: PubMed 28574965Langebeek 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.
- Background: PubMed 28121708Su 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.
- Background: PubMed 27683822Kooij 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.
- Background: PubMed 27513572Kooij 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.
- Background: PubMed 27149087Su 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.
- Background: PubMed 27143668van 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.
- Background: PubMed 27088320Kooij 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.
- Background: PubMed 27073222Cobos 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.
- Background: PubMed 27018841Demirkaya 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.
- Background: PubMed 26752277Schouten 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.
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HIV-1-infection
Active, not recruitingPhase 1/2
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Reiss, MD, PhD principal investigator
Amsterdam University Medical Centers, University of Amsterdam, Amsterdam; Amsterdam Institute for Global Health and Development, Amsterdam
Maria Prins, PhD principal investigator
Public Health Service Amsterdam, Amsterdam; Academic Medical Center, Amsterdam
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and Comorbidity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01466582, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.