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HIV Disease and Impairment of High Density Lipoprotein Metabolism

HIV Disease and Impairment of High Density Lipoprotein Metabolism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000691246
Acronym
Lipid 2
Enrollment
87
Registered
2018-04-27
Start date
2011-01-24
Completion date
2015-01-22
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Baker Heart and Diabetes Instutite
Lead SponsorCharities/Societies/Foundations

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026