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Impact of HIV and Its Treatment on Reverse Cholesterol Transport

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier:
NCT00168233
First received: September 9, 2005
Last updated: January 19, 2012
Last verified: January 2012
History of Changes

September 9, 2005
January 19, 2012
June 2005
September 2010   (final data collection date for primary outcome measure)
Not Provided
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.
Complete list of historical versions of study NCT00168233 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 over a 12 month period. .
  • 2. To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on endothelial function in HIV-infected patients over a 12 month period.
  • 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 over a 12 month period.
  • 4. To analyse factors which determine the rate of reverse cholesterol transport in HIV patients naive to therapy and during treatment with HAART
  • 5. To correlate use of protease inhibitors with defects in reverse cholesterol transport and clinical markers of atherosclerosis.
Not Provided
Not Provided
 
Impact of HIV and Its Treatment on Reverse Cholesterol Transport
Impact of HIV Infection and Treatment With Highly Active Antiretroviral Therapy on Reverse Cholesterol Transport

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

HIV infected patients naive to ARV therapy
HIV Infections
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
March 2011
September 2010   (final data collection date for primary outcome measure)

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

Exclusion criteria

  • Treatment with any form of lipid lowering drugs, including fish oils.
  • Body Mass Index greater than 27.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00168233
54/05
No
Jennifer Hoy, The Alfred
The Alfred
National Health and Medical Research Council, Australia
Study Director: Dmitri Sviridov, Dr Baker Heart Research Institute, Commercial Road, Melbourne
Principal Investigator: Jennifer Hoy, A/Prof Alfred Hospital, Melbourne, Vic 3004
The Alfred
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP