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

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.

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Key information

Conditions

HIV Infection Aging Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Research of Holdsworth House Medical Practice, Sydney, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Not Applicable

Treatment and study plan

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Acronym: Aging_in_HIV

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jan 26, 2016
Registry last updated: Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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