Trial registered on ANZCTR


Trial ID
ACTRN12607000622404
Ethics application status
Approved
Date submitted
27/11/2007
Date registered
5/12/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-parandial lipid effects of MK-0518 (raltegaravir) vs low-dose ritonavir (100mg daily) in HIV-negative adults
Scientific title
Post-parandial lipid effects of MK-0518 (raltegaravir) vs low-dose ritonavir (100mg daily) in HIV-negative adults
Secondary ID [1] 282886 0
Nil
Universal Trial Number (UTN)
Trial acronym
RoaR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human immunodeficiency virus (HIV) 2563 0
Condition category
Condition code
Infection 2664 2664 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular 2665 2665 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 2295 0
Treatment: drugs
Comparator / control treatment
ritonavir 100 mg oral per day fro 28 days
Control group
Active

Outcomes
Primary outcome [1] 3573 0
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.
Timepoint [1] 3573 0
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)
Secondary outcome [1] 5978 0
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)
Timepoint [1] 5978 0
Tonometry and respirometry, will be conducted at Visit 2 and Visit 4 (0hr,1hr,2hr,3hr,4hr,5hr,6hr)

Eligibility
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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics

Recruitment
Anticipated date of first participant enrolment
1/02/2008
Actual date of first participant enrolment
26/06/2008
Anticipated date last participant enrolled
Actual date last participant enrolled
4/03/2009
Anticipated date of last data collection
Actual date of last data collection
Target sample size
20
Actual sample size
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2806 0
Commercial sector/Industry
Name [1] 2806 0
Merck Sharpe and Dohme
Address [1] 2806 0
54-68 ferndell Street
South Granville
NSW 2142
Country [1] 2806 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
HIV Clinical Trials Unit
IBAC, Xavier Level 4
390 Victroia Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 2536 0
None
Name [1] 2536 0
Address [1] 2536 0
Country [1] 2536 0
Other collaborator category [1] 94 0
University
Name [1] 94 0
Garvan Institute of Medical Research
Address [1] 94 0
384 Victoris Street
Darlinghurst NSW 2010
Country [1] 94 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4798 0
St Vincents Hospital Sydney
Ethics committee address [1] 4798 0
Delacy 15 Building 390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 4798 0
Australia
Date submitted for ethics approval [1] 4798 0
28/11/2007
Approval date [1] 4798 0
Ethics approval number [1] 4798 0
HREC Reference No: 07/SVH/101HREC Reference No: 07/SVH/101

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28195 0
Prof Andrew Carr
Address 28195 0
St Vincents Hospital
Xavier, Level 4
390 Victoria St
Darlinghurst, NSW, 2010
Country 28195 0
Australia
Phone 28195 0
+61 2 8382 3359
Fax 28195 0
Email 28195 0
acarr@stvincents.com.au
Contact person for public queries
Name 11352 0
Mr Richard Norris
Address 11352 0
St Vincent's Hospital, Sydney
HIV Clinical Trials Unit,
IBAC Xavier Level 4
390 Victoria Street
Darlingurst NSW 2010
Country 11352 0
Australia
Phone 11352 0
02 8382 2435
Fax 11352 0
02 8382 2090
Email 11352 0
rnorris@stvincents.com.au
Contact person for scientific queries
Name 2280 0
Prof Professor Andrew Carr
Address 2280 0
St Vincent's Hospital, Sydney
HIV Clinical Trials Unit,
IBAC Xavier Level 4
390 Victoria Street
Darlingurst NSW 2010
Country 2280 0
Australia
Phone 2280 0
02 8382 3438
Fax 2280 0
02 8382 2090
Email 2280 0
acarr@stvincents.com.au