Impact of HIV and Its Treatment on Reverse Cholesterol Tr... | NCT00168233

Studies
Impact of HIV and Its Treatment on Reverse Cholesterol Transport

NCT00168233

Sponsor

The Alfred

Status

Completed

Last Update Posted

Jan 20, 2012Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

HIV Infections

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Sep 2010Actual

Completion Date

Mar 2011Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2012

Last Update Posted Date

Jan 20, 2012Estimated

Name	Class
National Health and Medical Research Council, Australia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HIV infected patients naive to ARV therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dmitri Sviridov, Dr	Baker Heart Research Institute, Commercial Road, Melbourne	Study Director
Jennifer Hoy, A/Prof	Alfred Hospital, Melbourne, Vic 3004	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alfred Hospital and Baker Heart Research Institute		Melbourne	Victoria	3004	Australia

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided