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

Aging Clinical Trial

— Aging_in_HIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663869
• Other study ID #: Aging with HIV
• Status: Completed
• Start date: September 2016
• Est. completion date: February 2018

Study information

• Verified date: April 2019
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Aging
• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
Australia	Department of Clinical Research of Holdsworth House Medical Practice	Sydney
Italy	Univeristy of Modena and ReggioEmilia	Modena
Spain	Hospital Clínic Per A La Recerca Biomèdica	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Countries where clinical trial is conducted

Australia,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year