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HIV Reverse Cholesterol Transport Study (HIV RCTS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by University College Dublin.
Recruitment status was:  Recruiting
Chelsea and Westminster NHS Foundation Trust
Information provided by (Responsible Party):
Patrick Mallon, University College Dublin Identifier:
First received: August 18, 2012
Last updated: January 25, 2013
Last verified: January 2013

Primary Objective:

To examine changes in expression of genes [particularly ABCA1 and SREBP2] involved in reverse cholesterol transport (RCT) in monocytes from HIV-infected subjects starting antiretroviral therapy and the different effect of NNRTI and PI based regimens

Secondary Objective:

To examine changes in monocyte intracellular cholesterol content in HIV-infected subjects starting antiretroviral therapy and the different effect of NNRTI and PI based regimens


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Antiretroviral Therapy and HIV on Reverse Cholesterol Transport in Blood( HIV Reverse Cholesterol Transport Study- HIV RCTS)

Resource links provided by NLM:

Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • Change in ABCA1 mRNA expression in monocytes [ Time Frame: June 2013 ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

HIV infection is associated with low HDL-cholesterol, an independent risk-factor for cardiovascular disease (CVD). NNRTI-based HAART increases HDL-c, with nevirapine shown to increase production of its major apolipoprotein ApoA-I. In contrast, initiation of PI-based HAART leads to persistently low HDL-c despite a reduction in HIV RNA and immunologic recovery.

HDL-c is formed through reverse cholesterol transport (RCT), the process where cholesterol is transferred from intracellular pools to circulating lipoproteins which are then eliminated by the liver. Accumulation of intracellular cholesterol in cells such as macrophages and their precursor (circulating monocytes) has been implicated in atherogenesis.

In vitro data suggests the HIV protein Nef directly interferes with cellular proteins involved in RCT such as ATP-binding cassette transporter A1 (ABCA1) in monocyte-derived macrophages. ABCA1 expression is controlled by peroxisome proliferator-activated receptor gamma (PPARG) and the intracellular cholesterol sensor sterol regulatory element binding protein 2 (SREBP2). In adipose tissue it is known that PI treatment downregulates SREBP and PPARG expression.

Preliminary work in the investigators lab has reproduced these findings in monocytes in untreated HIV infection in vivo and demonstrated relationships between gene expression for ABCA1, SREBP2, monocyte intracellular cholesterol and circulating lipoproteins. These early data suggest that defects in RCT determine intracellular cholesterol levels in HIV-infected subjects whereas increased LDL-c is a greater determinant of intracellular cholesterol in HIV negative subjects. This suggests a potentially pivotal role for RCT abnormalities in low HDL-c, increased intracellular cholesterol and atherogenesis in HIV infection.

The investigator's aim to examine the impact of initiation of ART with either PI or NNRTI on RCT in circulating monocytes in vivo and how this impact correlates with changes in amount and size of circulating HDL-c.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals starting antiretroviral therapy at the Mater Misericordiae University Hospital, Dublin, and Chelsea and Westminister Hospital, London

Inclusion Criteria:

  • > 18 years old
  • HIV-infected
  • Not currently on antiretroviral therapy (>6/12), but about to start

Exclusion Criteria:

  • On lipid lowering medication (statin / fibrate / niacin)
  • HCV Ab+
  Contacts and Locations
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Please refer to this study by its identifier: NCT01670968

Contact: Patrick WG Mallon, MB BCh FRACP FRCPI PhD +353 716 6311

United Kingdom
Chelsea & Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact: Anton Pozniak    +44 20 8746 8000   
Contact: Graeme Moyle    +44 20 8746 8000   
Principal Investigator: Anton Pozniak         
Sub-Investigator: Graeme Moyle         
Sponsors and Collaborators
University College Dublin
Chelsea and Westminster NHS Foundation Trust
Principal Investigator: Patrick WG Mallon, FRACP FRCPI PhD HIV Molecular Research Group, UCD School of Medicine and Medical Sciences. Department of Infectious Diseases, Mater Misericordiae University Hospital and Mater Private Hospital
  More Information

Responsible Party: Patrick Mallon, Associate Dean for Research and Innovation UCD School of Medicine and Medical Sciences, Consultant Infectious Diseases Physician, University College Dublin Identifier: NCT01670968     History of Changes
Other Study ID Numbers: HIV RCTS
Study First Received: August 18, 2012
Last Updated: January 25, 2013

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on April 28, 2017