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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02663869