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Trial registered on ANZCTR


Registration number
ACTRN12618000691246
Ethics application status
Approved
Date submitted
17/04/2018
Date registered
27/04/2018
Date last updated
27/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
HIV Disease and Impairment of High Density Lipoprotein Metabolism
Scientific title
HIV Disease and Impairment of High Density Lipoprotein Metabolism
Secondary ID [1] 294604 0
None
Universal Trial Number (UTN)
Trial acronym
Lipid 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 307427 0
Cardiovascular Disease 307428 0
Condition category
Condition code
Cardiovascular 306518 306518 0 0
Diseases of the vasculature and circulation including the lymphatic system
Infection 306519 306519 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To investigate the effects of HIV infection and anti-HIV treatment, we aim to recruit two groups of patients :-
a) HIV-infected males who are not on anti-HIV treatment.
b) HIV-infected males who are not on anti-HIV treatment but are about to commence post baseline visit.

To study our primary outcome (changes in high density lipoprotein), we collect blood from participants. Participants are asked to fast for a minimum of 10 hours prior to blood collection. Blood results will also tell us about their HIV progression, heart disease markers as well as lipid profile. We will also assess their artery health by measuring their arterial wall thickness (also known as carotid intima-media thickness or cIMT). These will be performed every year throughout the course of our 3 year study.
Intervention code [1] 300907 0
Not applicable
Comparator / control treatment
The control group consists of healthy, HIV-negative volunteers.
Control group
Active

Outcomes
Primary outcome [1] 305531 0
Our primary outcome is changes in High Density Lipoprotein (HDL) levels. From blood collected, we can measure HDL levels by using a blood analyser (COBAS by Roche Diagnostics).
Timepoint [1] 305531 0
HDL was assessed at baseline 1 2 and 3 years. 3 years is the primary timepoint
Secondary outcome [1] 345613 0
Changes in lipid profile assessed as a composite outcome of lipoprotein changes :-
Total cholesterol - assessed using blood analyser
HDL - assessed using blood analyser
LDL - assessed using blood analyser
apo-AI - assessed using blood analyser
apoB - assessed using blood analyser
triglycerides - assessed using blood analyser
Timepoint [1] 345613 0
Samples were collected at baseline 1 2 and 3 years post enrolment for assessment.
Secondary outcome [2] 345875 0
Change in heart disease marker as assessed using CRP measurement by serum assay kit
Timepoint [2] 345875 0
Samples were collected at baseline 1 2 and 3 years post enrolment for assessment.
Secondary outcome [3] 345876 0
Overall HIV disease progression assessed as a composite of :-
Viral load - assessed using information obtained from participant records
CD4+ counts -assessed using information obtained from participant records
CD4% - assessed using information obtained from participant records
Timepoint [3] 345876 0
Information was collected at baseline 1 2 and 3 years post enrolment for assessment.
Secondary outcome [4] 345958 0
Reverse cholesterol transport mechanism assessed as a composite of :-
LCAT - using assay assessment
CETP - using assay assessment
Timepoint [4] 345958 0
Samples were collected at baseline 1 2 and 3 years post enrolment for assessment.
Secondary outcome [5] 345959 0
HDL lipoprotein functionality assay assessed bycholesterol efflux using in-vitro experiments.
Timepoint [5] 345959 0
Samples were collected at baseline 1 2 and 3 years post enrolment for assessment.
Secondary outcome [6] 345960 0
HDL lipoprotein subfraction proportions assessed by HDL subfractions using in-vitro experiments
Timepoint [6] 345960 0
Samples were collected at baseline 1 2 and 3 years post enrolment for assessment.
Secondary outcome [7] 345961 0
Artery health assessed using cIMT measurements obtained by ultrasound on carotid artery
Timepoint [7] 345961 0
Measurements were collected at baseline 1 2 and 3 years post enrolment for assessment.
Secondary outcome [8] 345962 0
Heart disease marker assessed using HbA1c measurements obtained from participant records
Timepoint [8] 345962 0
Information was collected at baseline 1 2 and 3 years post enrolment for assessment.

Eligibility
Key inclusion criteria
Patients with confirmed diagnosis of HIV who are about to commence anti-HIV treatment.
Patients with confirmed diagnosis of HIV who are not commencing anti-HIV treatment.
Healthy controls
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Outside ages 18 and 60
lipid lowering medications (including fish oil supplements)
history of familial hypercholesterolemia
history of familial dyslipidemia
impaired liver function
high levels of alcohol consumption(<30 units or 250g of alcohol a week)
confirmed diagnosis of coronary art4ery disease
confirmed diagnosis of carotid/cerebral artery disease
peripheral artery disease

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Both
Statistical methods / analysis
Sample size calculation for this study was based on previous evidence for the primary outcome measure of High Density Lipoprotein (expected difference = 15%, SD = 0.15, alpha = 0.05, power = 0.8).

Results will be analysed using mixed-models for repeated measures using Stata.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/01/2011
Date of last participant enrolment
Anticipated
Actual
22/01/2015
Date of last data collection
Anticipated
Actual
8/12/2016
Sample size
Target
70
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10690 0
The Alfred - Prahran
Recruitment postcode(s) [1] 22412 0
3004 - Prahran
Recruitment outside Australia
Country [1] 10287 0
United States of America
State/province [1] 10287 0
Washington D.C
Country [2] 10288 0
Spain
State/province [2] 10288 0
Barcelona

Funding & Sponsors
Funding source category [1] 299223 0
Government body
Name [1] 299223 0
National Institute of Health
Country [1] 299223 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Baker Heart and Diabetes Instutite
Address
75 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 298489 0
University
Name [1] 298489 0
George Washington University
Address [1] 298489 0
2121 I St NW, Washington, DC 20052
Country [1] 298489 0
United States of America
Secondary sponsor category [2] 298497 0
University
Name [2] 298497 0
Bellvitge University Hospital
Address [2] 298497 0
Carrer de la Feixa Llarga, s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Spain
Country [2] 298497 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300145 0
Alfred Hospital Human Research and Ethics Committee
Ethics committee address [1] 300145 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 300145 0
Australia
Date submitted for ethics approval [1] 300145 0
Approval date [1] 300145 0
16/12/2010
Ethics approval number [1] 300145 0
377.10

Summary
Brief summary
Research indicates that people living with HIV have higher risk of heart disease. This is partly due to the effects of anti-HIV drugs, and partly due to the effects of HIV itself, however it is not understood how HIV might cause heart disease. We intend to collect information from participants to help compare the changes in the structure and function of 'good cholesterol' or high density lipoprotein (HDL) which are known to be affected by HIV and treatment for HIV. In addition, we intend to study traditional risk factors of heart disease such as cholesterol levels and artery health to understand how they change with HIV disease indicators such as viral load and CD4 cell count.

To do this, we will recruit three groups of participants. a) HIV-positive participants who are not on anti-HIV treatment, b) HIV-positive participants who are about to commence their anti-HIV treatment and c) healthy matched controls. At baseline, participants will be asked to complete a lifestyle and clinical observation survey and blood will be collected for laboratory analysis. Bloods will provide us with information on their HDL, lipid profile, heart disease markers as well as HIV progression. Participants will also have the wall of their carotid artery assessed by ultrasound, a measurement known as carotid intima-media thickness (cIMT) as an indicator of artery health. Participants will be followed-up once a year for three years (four visits in total). At each visit, anthropometric, bloods and cIMT measurements are collected.

This information may lead to the development of new markers of heart disease for physicians to better monitor and treat heart disease in people living with HIV.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82698 0
Prof Dmitri Sviridov
Address 82698 0
Baker Heart and Diabetes Institute
75 Commercial Road,
Melbourne VIC 3004
Country 82698 0
Australia
Phone 82698 0
+61385321363
Fax 82698 0
+61385321111
Email 82698 0
[email protected]
Contact person for public queries
Name 82699 0
Cath Downs
Address 82699 0
Infectious Disease Unit
Level 2, Burnet Institute, Alfred Hospital
85 Commercial Road
Melbourne VIC 3004
Country 82699 0
Australia
Phone 82699 0
+61390766908
Fax 82699 0
+61390762431
Email 82699 0
[email protected]
Contact person for scientific queries
Name 82700 0
Dmitri Sviridov
Address 82700 0
Baker Heart and Diabetes Institute
75 Commercial Road,
Melbourne VIC 3004
Country 82700 0
Australia
Phone 82700 0
+61385321363
Fax 82700 0
+61385321111
Email 82700 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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