HIV InfectionAging_in_HIVNCT02663869
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
An observational study of HIV Infection and Aging, run by University of Modena and Reggio Emilia at 3 sites in 3 countries.
Trial summary
Clinical hypotheses: The increasing number of people aging with HIV is a matter of fact. Differences in prevalence of comorbidities between the general population and HIV-positive patients are mainly driven by duration of HIV infection rather than chronological age of HIV+ patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Aging
- How many people
- 131 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2016to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV infected and not infected people
Who may be able to join
- HIV Aging-Old patients will be selected at Modena HIV metabolic Clinic. 200 consecutive patients who satisfy the following criteria:
- HIV + since 20 year
- HIV diagnosis occurred when the patient was older than 30 years
- HIV negative test within 5 years prior HIV diagnosis
- Multidisciplinary evaluation for comorbidities was performed during 2014
- On HAART for at least 1 year
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- HIV Aging-Young patients will be selected at Romanian HIV Cohort. 200 consecutive patients who satisfy the following criteria:
- HIV + since 20 year
- HIV diagnosis occurred when the patient was younger than 5 years
- Multidisciplinary evaluation for comorbidities was performed during 2014
- On HAART for at least 1 year
Who cannot join
- Not Applicable
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Australia1 site
Department of Clinical Research of Holdsworth House Medical Practice
Sydney
About this study
Clinical hypotheses:
The increasing number of people aging with HIV is a matter of fact. Differences in prevalence of comorbidities between the general population and HIV-positive patients are mainly driven by duration of HIV infection rather than chronological age of HIV+ patients.
Read more
People aging with HIV display heterogeneous health conditions. Host factors and duration of HIV infection are associated with increased risk of MM, independently from chronological age and these factors are responsible of the prevalence difference of comorbidities and MM in comparison to the general population.
Objectives:
The study objective is to assess the prevalence of, and risk factors for, individual co-morbidities and multi morbidity (MM) between HIV-positive patients with similar duration of HIV infection, but 30 years difference. We compared estimates across both groups to a matched community-based cohort sampled from the general population.
Read the detailed description
This study is a case-control study, including antiretroviral therapy (ART)-experienced patients, coming from the two following cohorts:
- Modena HIV Metabolic Clinic (MHMC) cohort and
- Romanian HIV cohort (RHC). For this study only patients living with HIV ≥ 20 years will belong to these two cohort. The Aging-Young patients acquired HIV infection in childhood, and Aging-old patients acquired HIV infection above the age of 30.
Aging-Young patients will be matched to Aging-Old patients considering gender and HIV duration (within 1 year interval) (This is the most important matching criteria. The exact number of year of HIV duration since HIV test is the major criteria). An HIV negative test within 5 years prior HIV diagnosis is required in the selection of patients from MHMC to avoid an unpredicted HIV time exposure in these patients.
Then, Aging-young and Aging-old patients will be age, gender matched with a 1: 3 ratio with CINECA (Consorzio Interuniversitario di Calcolo) "ARNO" records (control group, called "HIV-negative group"). The study will analyse 200 HIV Aging-Young and 200 HIV Aging-Old patients in comparison to 1200 controls.
In the first set of analyses, the prevalence of non-infectious comorbidities (NICM) and multimorbidities (MM) in HIV Aging-Young and in HIV Aging-Old groups will be compared to those of HIV-negative group using multivariable logistic regression models. In the second set of analyses, the probability of MM in the HIV Aging-Young cohort will be compared to the HIV Aging-Old one, using multivariable logistic regression models.
- Conditions
- HIV Infection, Aging
- Medical subject headings
- HIV Infections
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 Aging-Young | 200 patients | |
| HIV Aging-Old | 200 patients | |
| controls | 1200 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the prevalence of co-morbidities and multimorbidity between HIV-positive patients with similar duration of HIV infection, but 30 years difference
Multimorbidity is assessed by physician based on the concurrent presence of > 2 non infectious comorbidities (hypertension, cardiovascular disease, diabetes, etc)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Guaraldi, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663869
- Sponsor's protocol ID
- Aging with HIV
- Acronym
- Aging_in_HIV
- Status last verified
- Apr 2019
- First submitted
- 21 Dec 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
- ClinicalTrials.gov ID
- NCT02663869
- Acronym / sponsor ID
- Aging_in_HIV / Aging with HIV
- Conditions
- HIV Infection, Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 26 Jan 2016 (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.
Clinical hypotheses:
The increasing number of people aging with HIV is a matter of fact. Differences in prevalence of comorbidities between the general population and HIV-positive patients are mainly driven by duration of HIV infection rather than chronological age of HIV+ patients.
People aging with HIV display heterogeneous health conditions. Host factors and duration of HIV infection are associated with increased risk of MM, independently from chronological age and these factors are responsible of the prevalence difference of comorbidities and MM in comparison to the general population.
Objectives:
The study objective is to assess the prevalence of, and risk factors for, individual co-morbidities and multi morbidity (MM) between HIV-positive patients with similar duration of HIV infection, but 30 years difference. We compared estimates across both groups to a matched community-based cohort sampled from the general population.
Detailed description
This study is a case-control study, including antiretroviral therapy (ART)-experienced patients, coming from the two following cohorts:
- Modena HIV Metabolic Clinic (MHMC) cohort and
- Romanian HIV cohort (RHC). For this study only patients living with HIV ≥ 20 years will belong to these two cohort. The Aging-Young patients acquired HIV infection in childhood, and Aging-old patients acquired HIV infection above the age of 30.
Aging-Young patients will be matched to Aging-Old patients considering gender and HIV duration (within 1 year interval) (This is the most important matching criteria. The exact number of year of HIV duration since HIV test is the major criteria). An HIV negative test within 5 years prior HIV diagnosis is required in the selection of patients from MHMC to avoid an unpredicted HIV time exposure in these patients.
Then, Aging-young and Aging-old patients will be age, gender matched with a 1: 3 ratio with CINECA (Consorzio Interuniversitario di Calcolo) "ARNO" records (control group, called "HIV-negative group"). The study will analyse 200 HIV Aging-Young and 200 HIV Aging-Old patients in comparison to 1200 controls.
In the first set of analyses, the prevalence of non-infectious comorbidities (NICM) and multimorbidities (MM) in HIV Aging-Young and in HIV Aging-Old groups will be compared to those of HIV-negative group using multivariable logistic regression models. In the second set of analyses, the probability of MM in the HIV Aging-Young cohort will be compared to the HIV Aging-Old one, using multivariable logistic regression models.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV Aging-Young | – | –200 patients |
| HIV Aging-Old | – | –200 patients |
| controls | – | –1200 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected and not infected people
Key inclusion criteria (11 listed)
- HIV Aging-Old patients will be selected at Modena HIV metabolic Clinic. 200 consecutive patients who satisfy the following criteria:
- HIV Aging-Young patients will be selected at Romanian HIV Cohort. 200 consecutive patients who satisfy the following criteria:
Key exclusion criteria (1 listed)
- Not Applicable
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
Assess the prevalence of co-morbidities and multimorbidity between HIV-positive patients with similar duration of HIV infection, but 30 years difference
Time frame: 1 year
Multimorbidity is assessed by physician based on the concurrent presence of > 2 non infectious comorbidities (hypertension, cardiovascular disease, diabetes, etc)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Aging, run by University of Modena and Reggio Emilia at 3 sites in 3 countries.
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 11 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: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Italy, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the prevalence of co-morbidities and multimorbidity between HIV-positive patients with similar duration of HIV infection, but 30 years difference (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2019.