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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02663869




Registration number
NCT02663869
Ethics application status
Date submitted
21/12/2015
Date registered
26/01/2016
Date last updated
17/04/2019

Titles & IDs
Public title
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Scientific title
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Secondary ID [1] 0 0
Aging with HIV
Universal Trial Number (UTN)
Trial acronym
Aging_in_HIV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Aging 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
HIV Aging-Young - 200 patients

HIV Aging-Old - 200 patients

controls - 1200 patients
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess the prevalence of co-morbidities and multimorbidity between HIV-positive patients with similar duration of HIV infection, but 30 years difference
Timepoint [1] 0 0
1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Not Applicable

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2018
Sample size
Target
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Clinical Research of Holdsworth House Medical Practice - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Modena
Country [2] 0 0
Spain
State/province [2] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Other
Name
University of Modena and Reggio Emilia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02663869
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02663869