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
  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 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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jennifer Hoy, Professor Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier: NCT00168233     History of Changes
Other Study ID Numbers: 54/05
Study First Received: September 9, 2005
Last Updated: January 19, 2012
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by The Alfred:
Treatment Naive
HIV

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 26, 2014