Trial from ANZCTR


Trial ID ACTRN12607000622404
Trial Status: Registered
Date Submitted: 27/11/2007
Date Registered: 5/12/2007
Prospectively registered

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Public title Post-parandial lipid effects of MK-0518 (raltegaravir) vs low-dose ritonavir (100mg daily) in HIV-negative adults
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Post-parandial lipid effects of MK-0518 (raltegaravir) vs low-dose ritonavir (100mg daily) in HIV-negative adults
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Secondary ID [1] 282886 0
Nil
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UTN
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Trial acronym RoaR
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Health condition(s) or problem(s) studied:
Human immunodeficiency virus (HIV) 2563 0
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Condition category: Condition code:
Infection Acquired immune deficiency syndrome (AIDS / HIV)
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2664 2664 0 0
Cardiovascular Normal development and function of the cardiovascular system
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2665 2665 0 0

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Descriptions of intervention(s) / exposure To compare the effects of oral dose ritonavir (RTV) 100mg daily for 28 days to oral dose raltegravir 400mg twice a day for 28 days.
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Treatment: drugs 2295 0
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Comparator / control treatment ritonavir 100 mg oral per day fro 28 days
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Control group Active
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Primary Outcome: To compared the effects of ritonavir (RTV) 100mg daily to those of raltegravir 400mg twice a day on postprandil triglyceride levels in healthy adults over four weeks. 3573 0
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Timepoint: Blood measurements at Visit 1 (Screening -2 to -14 day), Visit 2 (Baseline, 0 hr, 1hr, 2hr, 3hr, 4hr, 5hr, 6hr) and Visit 4 (Week 4, 0hr,1hr, 2hr,3hr,4hr,5hr,6hr) 3573 0
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Secondary Outcome: Comparison of post-prandial lipid effect of oral dose ritonavir 100mg daily and oral dose raltegravir 400mg twice a day. Measure menat of patient lipid laboratory bloods, radial artery tonometry ( measure the function of your arteries and done by placing a probe over the artery in your wrist for about 3o seconds) and Respirometry, (this test measures the speed of your metabolism, as well as the rate at which fats and sugars are metabolised in the body) 5978 0
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Timepoint: Tonometry and respirometry, will be conducted at Visit 2 and Visit 4 (0hr,1hr,2hr,3hr,4hr,5hr,6hr) 5978 0
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Key inclusion criteria 1. adults taking a 'normal diet' with a stable weight and no desire to lose or gain weight
body mass index between 20and 30kg/m2
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? Yes
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Key exclusion criteria 1. HIV infection
2.use of any medication contra-indictaed with RTG or RTV
3. Fsting triglycerides < 2.0 mmol/l (176 mg/dl)
4. Fasting total cholestrol <6.0 mmol/l (233 mg/dl)
5. use of lipid-lowering therapy
6. Use of anti-hypertensive therapy
7. Diabetes mellitus (fsting glucose >7.0 mmol/l or a prior diagnosis of diabetes)
8. serum hepatic transaminases (AST/ALT) greater than 3 times the upper limit of normal
9. pregnancy or breast feeding
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Pharmacokinetics / pharmacodynamics
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Statistical Methods/Analysis
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Phase Phase 4
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Anticipated date of first participant enrolment 1/02/2008
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Date of first participant enrolment 26/06/2008
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled 4/03/2009
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Target sample size 20
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Commercial sector/Industry 2806 0
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Name: Merck Sharpe and Dohme 2806 0
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Address: 54-68 ferndell Street
South Granville
NSW 2142
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Country: Australia 2806 0
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Primary Sponsor Hospital
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Name: St Vincent's Hospital Sydney
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Address: HIV Clinical Trials Unit
IBAC, Xavier Level 4
390 Victroia Street
Darlinghurst NSW 2010
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Country: Australia
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Secondary Sponsor: None 2536 0
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Name: 2536 0
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Address: 2536 0
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Country: 2536 0
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Other Collaborator: University 94 0
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Name: Garvan Institute of Medical Research 94 0
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Address: 384 Victoris Street
Darlinghurst NSW 2010
94 0
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Country: Australia 94 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: St Vincents Hospital Sydney 4798 0
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Address: Delacy 15 Building 390 Victoria Street
Darlinghurst NSW 2010
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Country: Australia 4798 0
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Approval Date: 4798 0
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Submitted Date: 28/11/2007 4798 0
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HREC: HREC Reference No: 07/SVH/101HREC Reference No: 07/SVH/101 4798 0
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Brief summary A randomized, open-label, 4 week trial. Twenty (22) eligible participants will be randomly assigned to receive 1:1 to raltegravir 400mg bid or ritonavir 100mg mane with food.

Planned sample size: Twenty two (22) eligible participants.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Prof
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Name: Andrew Carr
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Address: St Vincents Hospital Xavier, Level 4 390 Victoria St Darlinghurst, NSW, 2010
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Country: Australia
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Tel: +61 2 8382 3359
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Fax:
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Email: acarr@stvincents.com.au
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Contact person for public queries
Title: Mr
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Name: Richard Norris
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Address: St Vincent's Hospital, Sydney HIV Clinical Trials Unit, IBAC Xavier Level 4 390 Victoria Street Darlingurst NSW 2010
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Country: Australia
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Tel: 02 8382 2435
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Fax: 02 8382 2090
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Email: rnorris@stvincents.com.au
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Contact person for scientific queries
Title: Prof
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Name: Professor Andrew Carr
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Address: St Vincent's Hospital, Sydney HIV Clinical Trials Unit, IBAC Xavier Level 4 390 Victoria Street Darlingurst NSW 2010
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Country: Australia
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Tel: 02 8382 3438
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Fax: 02 8382 2090
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Email: acarr@stvincents.com.au
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Contact person responsible for updating information
Title: Mr
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Name: Richard Norris
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Address: St Vincent's Hospital, Sydney HIV Clinical Trials Unit, IBAC Xavier Level 4 390 Victoria Street Darlingurst NSW 2010
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Country: Australia
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Tel: 02 8382 2435
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Fax: 02 8382 2090
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Email: rnorris@stvincents.com.au
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Addition Cancer fields
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