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Impact of HIV and Its Treatment on Reverse Cholesterol Transport

This study is currently recruiting participants.
Verified by The Alfred, May 2008

Sponsors and Collaborators: The Alfred
National Health and Medical Research Council, Australia
Information provided by: The Alfred
ClinicalTrials.gov Identifier: NCT00168233
  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

MedlinePlus related topics:   AIDS    AIDS Medicines    Cholesterol   

ChemIDplus related topics:   Cholest-5-en-3-ol (3beta)-   

U.S. FDA Resources

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

Further study details as provided by The Alfred:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   75
Study Start Date:   June 2005
Estimated Study Completion Date:   June 2009

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168233

Contacts
Contact: Jennifer Hoy, A/Prof     0061 3 9276 6900     Jennifer.Hoy@med.monash.edu.au    

Locations
Australia, Victoria
Alfred Hospital and Baker Heart Research Institute     Recruiting
      Melbourne, Victoria, Australia, 3004
      Contact: Jennifer Hoy, A/Prof     0061 3 9276 6900     Jennifer.Hoy@med.monash.edu.au    

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:   The Alfred ( Prof Jennifer Hoy )
Study ID Numbers:   54/05
First Received:   September 9, 2005
Last Updated:   May 19, 2008
ClinicalTrials.gov Identifier:   NCT00168233
Health Authority:   Australia: National Health and Medical Research Council

Keywords provided by The Alfred:
Treatment Naive  
HIV  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on September 22, 2008




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