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Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2017 by Giovanni Guaraldi, University of Modena and Reggio Emilia

Sponsor
University of Modena and Reggio Emilia


Information provided by (Responsible Party)
Giovanni Guaraldi, University of Modena and Reggio Emilia

ClinicalTrials.gov Identifier
NCT02663869

First received: December 21, 2015
Last updated: May 2, 2017
Last Verified: May 2017
History of Changes
Purpose

Purpose

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
HIV Infection
Aging

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles

Further study details as provided by Giovanni Guaraldi, University of Modena and Reggio Emilia:

Primary Outcome Measures

  • 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)

Estimated Enrollment: 1600
Study Start Date: September 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Arms
HIV Aging-Young
200 patients
HIV Aging-Old
200 patients
controls
1200 patients

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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:

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02663869

Contacts

Contact:   Giovanni Guaraldi giovanni.guaraldi@unimore.it

Locations

Australia
Department of Clinical Research of Holdsworth House Medical Practice Recruiting
Sydney, Australia
Contact: Mark Bloch
Italy
Univeristy of Modena and ReggioEmilia Recruiting
Modena, Italy, 41124
Contact: Giovanni Guaraldi
Spain
Hospital Clínic Per A La Recerca Biomèdica Recruiting
Barcelona, Spain
Contact: Esteban Martinez

Sponsors and Collaborators

University of Modena and Reggio Emilia
More Information

More Information


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  
Study First Received: December 21, 2015  
Last Updated: May 2, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.