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Impact of HIV and Its Treatment on Reverse Cholesterol Transport

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168233
First Posted: September 15, 2005
Last Update Posted: January 20, 2012
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Jennifer Hoy, The Alfred
  Purpose
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.

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of HIV Infection and Treatment With Highly Active Antiretroviral Therapy on Reverse Cholesterol Transport

Resource links provided by NLM:


Further study details as provided by Jennifer Hoy, The Alfred:

Enrollment: 44
Study Start Date: June 2005
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV infected patients naive to ARV therapy
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168233


Locations
Australia, Victoria
Alfred Hospital and Baker Heart Research Institute
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
National Health and Medical Research Council, Australia
Investigators
Study Director: Dmitri Sviridov, Dr Baker Heart Research Institute, Commercial Road, Melbourne
Principal Investigator: Jennifer Hoy, A/Prof Alfred Hospital, Melbourne, Vic 3004
  More Information

Responsible Party: Jennifer Hoy, Professor Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier: NCT00168233     History of Changes
Other Study ID Numbers: 54/05
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by Jennifer Hoy, The Alfred:
Treatment Naive
HIV

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases