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Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles (Aging_in_HIV)

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ClinicalTrials.gov Identifier: NCT02663869
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Giovanni Guaraldi, University of Modena and Reggio Emilia

Brief 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.

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.


Condition or disease
HIV Infection Aging

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.


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Study Type : Observational
Actual Enrollment : 131 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Actual Study Start Date : September 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
HIV Aging-Young
200 patients
HIV Aging-Old
200 patients
controls
1200 patients



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV infected and not infected people
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663869


Locations
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Australia
Department of Clinical Research of Holdsworth House Medical Practice
Sydney, Australia
Italy
Univeristy of Modena and ReggioEmilia
Modena, Italy, 41124
Spain
Hospital Clínic Per A La Recerca Biomèdica
Barcelona, Spain
Sponsors and Collaborators
University of Modena and Reggio Emilia

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Responsible Party: Giovanni Guaraldi, MD, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT02663869     History of Changes
Other Study ID Numbers: Aging with HIV
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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