Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000494639
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
23/09/2005
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
Date results provided
21/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of HIV and its treatment on reverse cholesterol transport
Scientific title
Impact of HIV infection and treatment with Highly Active Antiretroviral therapy on Reverse Cholesterol Transport
Secondary ID [1] 304545 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 617 0
Atherosclerosis 618 0
Condition category
Condition code
Infection 690 690 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular 691 691 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To compare untreated HIV-infected patients (patients who will not require therapy for the entire study duration of 12 months) with:
HIV-infected patients that are PI naïve and initiating therapy with a protease inhibitor containing HAART regime (ARV naïve or NNRTI experienced changing to PI regimen) at study baseline
and:
HIV-infected patients naïve to ARV therapy and initiating NNRTI-containing regimen at baseline of the study.
The participants will remain in the study for a durtation of 12 months on the same medication as at baseline. This study will not influence the therapeutic management of the participants. Patients who have to change therapy during the study with be withdrawn.
Intervention code [1] 641 0
None
Comparator / control treatment
Untreated HIV infection
Control group
Uncontrolled

Outcomes
Primary outcome [1] 842 0
To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on reverse cholesterol transport in HIV-infected patients in a prospective study over a 12 month period.
Timepoint [1] 842 0
12 months
Secondary outcome [1] 1675 0
1.To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on individual steps of reverse cholesterol transport in HIV-infected patients.
Timepoint [1] 1675 0
Over a 12 month period.
Secondary outcome [2] 1676 0
2.To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on endothelial function in HIV-infected patients.
Timepoint [2] 1676 0
Over a 12 month period.
Secondary outcome [3] 1677 0
3. To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on intima-media thickness (atherosclerotic development) in HIV-infected patients.
Timepoint [3] 1677 0
Over a 12 month period.
Secondary outcome [4] 1678 0
4.To analyse factors which determine the rate of reverse cholesterol transport in HIV patients naive to therapy and during treatment with HAART.
Timepoint [4] 1678 0
N/A
Secondary outcome [5] 1679 0
5. To correlate use of protease inhibitors with defects in reverse cholesterol transport and clinical markers of atherosclerosis.
Timepoint [5] 1679 0
N/A

Eligibility
Key inclusion criteria
Male patients with HIV infection. 3 groups of 50 patients each. HIV infected patients, naive to ARV therapy and not likely to need to commence therapy for the duration of follow-up (12 months). HIV-infected patients, PI naive, initiating therapy with PI-containing HAART (ARV naïve or NNRTI experienced changing to PI regimen). HIV-infected patients naive to ARV therapy, initiating NNRTI-containing regimen.
Minimum age
Not stated
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Treatment with any form of lipid lowering drugs, including fish oils. Body Mass Index greater than 27.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2005
Actual
13/07/2005
Date of last participant enrolment
Anticipated
Actual
1/06/2007
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
150
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 766 0
Government body
Name [1] 766 0
National Health and Medical Research Council of Australia (grants # 317811 and 317810(DS)
Country [1] 766 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council of Australia (grants # 317811 and 317810(DS)
Address
Baker Institute, Commercial Rd, Melbourne
Country
Australia
Secondary sponsor category [1] 309834 0
None
Name [1] 309834 0
Address [1] 309834 0
Country [1] 309834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2011 0
Alfred Hospital
Ethics committee address [1] 2011 0
Ethics committee country [1] 2011 0
Australia
Date submitted for ethics approval [1] 2011 0
Approval date [1] 2011 0
Ethics approval number [1] 2011 0
Ethics committee name [2] 2012 0
Baker Heart Research Institute
Ethics committee address [2] 2012 0
Ethics committee country [2] 2012 0
Australia
Date submitted for ethics approval [2] 2012 0
Approval date [2] 2012 0
23/03/2005
Ethics approval number [2] 2012 0
Ethics committee name [3] 2013 0
Monash Medical Centre
Ethics committee address [3] 2013 0
Ethics committee country [3] 2013 0
Australia
Date submitted for ethics approval [3] 2013 0
Approval date [3] 2013 0
Ethics approval number [3] 2013 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35387 0
Prof Jennifer Hoy
Address 35387 0
Alfred Hospital, 85 Commercial Rd, Melbourne, Victoria, 3004
Country 35387 0
Australia
Phone 35387 0
+61 3 9076 6900
Fax 35387 0
Email 35387 0
[email protected]
Contact person for public queries
Name 9830 0
Associate Professor Jennifer Hoy
Address 9830 0
Infectious Diseases Unit
Alfred Hospital
2nd Floor
Burnet Institute
Commercial Rd
Prahran VIC 3004
Country 9830 0
Australia
Phone 9830 0
+61 3 92766900
Fax 9830 0
+61 3 92762431
Email 9830 0
[email protected]
Contact person for scientific queries
Name 758 0
Dr. Dmitri Sviridov
Address 758 0
Lipoproteins and Atherosclerosis Laboratory
Baker Heart Research Institute
Commercial Rd
Prahran VIC 3181
Country 758 0
Australia
Phone 758 0
+61 3 85321363
Fax 758 0
+61 3 85321100
Email 758 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.