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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00168233




Registration number
NCT00168233
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
20/01/2012

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] 0 0
54/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
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
1 - No antiretroviral therapy for 12 months

2 - Initiating ARV therapy with an NNRTI based regimen

3 - Initiating ARV therapy with a PI based regimen
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Male patients with HIV infection (3 groups of 50 patients each)

- HIV infected patients, naïve to ARV therapy and not likely to need to commence therapy
for the duration of follow-up (12 months)

- HIV-infected patients, PI naïve, initiating therapy with PI-containing HAART (ARV
naïve or NNRTI experienced changing to PI regimen)

- HIV-infected patients naïve to ARV therapy, initiating NNRTI-containing regimen
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- Treatment with any form of lipid lowering drugs, including fish oils.

- Body Mass Index greater than 27.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital and Baker Heart Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To investigate the effect of treatment of HIV infection with highly active antiretroviral
therapy on individual steps of reverse cholesterol transport, endothelial function and
intima-media thickness in HIV patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00168233
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dmitri Sviridov, Dr
Address 0 0
Baker Heart Research Institute, Commercial Road, Melbourne
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/ct2/show/NCT00168233