NCT00168233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

5.3 years

First QC Date

September 9, 2005

Last Update Submit

January 19, 2012

Conditions

HIV Infections

Keywords

Treatment NaiveHIV

Study Arms (3)

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 Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV infected patients naive to ARV therapy

You may qualify if:

  • 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

You may not qualify if:

  • Treatment with any form of lipid lowering drugs, including fish oils.
  • Body Mass Index greater than 27.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital and Baker Heart Research Institute

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Dmitri Sviridov, Dr

    Baker Heart Research Institute, Commercial Road, Melbourne

    STUDY DIRECTOR

  • Jennifer Hoy, A/Prof

    Alfred Hospital, Melbourne, Vic 3004

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jennifer Hoy

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

June 1, 2005

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

AU(1)