Impact of HIV and Its Treatment on Reverse Cholesterol Transport

This study is currently recruiting participants.

Verified by The Alfred, May 2008

First Received: September 9, 2005 Last Updated: May 19, 2008 History of Changes

Sponsor:	The Alfred
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines Cholesterol

U.S. FDA Resources

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

No publications provided

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

Keywords provided by The Alfred:

Treatment Naive
HIV

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010