Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000917033
Ethics application status
Approved
Date submitted
20/10/2010
Date registered
28/10/2010
Date last updated
22/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-prandial lipid effects of ritonavir-boosted atazanavir vs ritonavir-boosted darunavir in HIV-uninfected adults
Scientific title
To compare the effects of ritonavir-boosted atazanavir (AZV 300mg / RTV 100mg once daily) to ritonavir-boosted darunavir (DRV 800mg / RTV 100mg once daily) over 4 weeks on postprandial lipids in healthy volunteers.
Secondary ID [1] 252952 0
rAD
Universal Trial Number (UTN)
U1111-1117-5291
Trial acronym
rAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post prandial lipid disturbances associated with Atazanavir-Ritonavir vs Darunavir-Ritonavir 258447 0
Condition category
Condition code
Infection 258612 258612 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular 258613 258613 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 ritonavir-boosted atazanavir (AZV 300mg / RTV 100mg once daily) to oral ritonavir-boosted darunavir (DRV 800mg / RTV 100mg once daily) over 4 weeks.
Intervention code [1] 257443 0
Treatment: Drugs
Comparator / control treatment
oral tablets ritonavir-boosted darunavir (DRV 800mg / RTV 100mg once daily) over 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 259461 0
To compare the effects of ritonavir-boosted atazanavir (AZV 300mg / RTV 100mg once daily) to ritonavir-boosted darunavir (DRV 800mg / RTV 100mg once daily) over 4 weeks on postprandial lipids in healthy volunteers.
Timepoint [1] 259461 0
Blood measurements at screening visit, baseline and week 4 at timepoints:premeal, post meal 1 hr, 2 hrs, 3 hrs and 4 hrs.
Blood measurements are collected at week 2 once.
Secondary outcome [1] 266020 0
To compare the effects of ritonavir-boosted atazanavir (AZV 300mg / RTV 100mg once daily) to ritonavir-boosted darunavir (DRV 800mg / RTV 100mg once daily) over 4 weeks on:
safety
Timepoint [1] 266020 0
liver function tests are performed at screening visit, baseline and week 4 at timepoints:premeal, post meal 1 hr, 2 hrs, 3 hrs and 4 hrs.
these blood tests are collected at week 2 once.
Secondary outcome [2] 266091 0
glycaemic responses
Timepoint [2] 266091 0
glucose and insulin measurements at screening visit, baseline and week 4 at timepoints:premeal, post meal 1 hr, 2 hrs, 3 hrs and 4 hrs.
Secondary outcome [3] 266092 0
C-reactive protein and D-dimer
Timepoint [3] 266092 0
C-reactive protein and D-dimer measurements at baseline and week 4 visits at timepoints:premeal, post meal 2 hrs and 4 hrs.
Blood measurements are also collected at week 2 once.
Secondary outcome [4] 266093 0
aterial stiffness
Timepoint [4] 266093 0
measured by performing radial artery tonomerry at baseline and week 4 at timepoints:premeal, post meal 1 hr, 2 hrs, 3 hrs and 4 hrs.
also measured at week 2.

Eligibility
Key inclusion criteria
1.Provision of signed, informed consent
2.Adults taking their “normal diet” (stable intake for each participant) with a stable weight and no desire to lose or gain weight
3.Body mass index between 20 and 30 kg/m2
4.Fasting triglycerides < 2.0 mmol/l
5.Fasting total cholesterol < 6.0 mmol/l
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
6.HIV infection (antibody, western blot, proviral DNA)
7.Use of any medication contra-indicated with RTV, AZV or DRV
8.Use of lipid-lowering therapy
9.Use of anti-hypertensive therapy
10.Diabetes mellitus (fasting glucose > 7.0 mmol/l or a prior diagnosis of diabetes)
11.Serum hepatic transaminases (ALT / AST) greater than 3 times the upper limit of normal
12.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)
This is a randomized, open-label, 4-week trial. Twenty (20) eligible participants will be randomly allocated 1:1 to receive:
i) ritonavir-boosted atazanavir (AZV 300mg / RTV 100mg) once daily for four (4) weeks
OR
ii) ritonavir-boosted darunavir (DRV 800mg / RTV 100mg) once daily for four (4) weeks


Method of allocation to the above is conducted by a blinded 'third party' using sealed opaque envelopes using the method of 'block randomisation'.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation will be randomised according to the method of “block randomisation” to balance the number of patients recruited in each treatment arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2010
Actual
12/10/2010
Date of last participant enrolment
Anticipated
Actual
1/11/2011
Date of last data collection
Anticipated
Actual
14/12/2011
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 3367 0
2010

Funding & Sponsors
Funding source category [1] 257894 0
Self funded/Unfunded
Name [1] 257894 0
Country [1] 257894 0
Primary sponsor type
Hospital
Name
St vincents Hospital
Address
390 Victoria St,
Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 257089 0
None
Name [1] 257089 0
Address [1] 257089 0
Country [1] 257089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259912 0
St Vincents Hospital Human Research Ethics Committee
Ethics committee address [1] 259912 0
Ethics committee country [1] 259912 0
Date submitted for ethics approval [1] 259912 0
Approval date [1] 259912 0
Ethics approval number [1] 259912 0

Summary
Brief summary
This is a randomized, open-label, 4-week trial. Twenty (20) eligible participants will be randomly allocated 1:1 to receive:

i) ritonavir-boosted atazanavir (AZV 300mg / RTV 100mg) once daily for four (4) weeks
OR
ii) ritonavir-boosted darunavir (DRV 800mg / RTV 100mg) once daily for four (4) weeks

Planned sample size: Twenty (20) eligible participants who complete the 4 week study
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31805 0
Prof Andrew Carr
Address 31805 0
St Vincents Hospital
Xavier, Level 4, 390 victoria St
Darlinghurst, NSW, 2010
Country 31805 0
Australia
Phone 31805 0
+61 2 83823359
Fax 31805 0
Email 31805 0
[email protected]
Contact person for public queries
Name 15052 0
Ms Nicola Mackenzie
Address 15052 0
St Vincents Centre for Applied Medical Research
Clinical Research Program
Level 4, Xavier Building
390 Victoria St
Darlinghurst
NSW 2010
Country 15052 0
Australia
Phone 15052 0
+61 2 8382 2919
Fax 15052 0
+61 2 8382 3869
Email 15052 0
[email protected]
Contact person for scientific queries
Name 5980 0
Prof Professor andrew Carr
Address 5980 0
St Vincents Centre for Applied Medical Research
Clinical Research Program
Level 4, Xavier Building
390 Victoria St
Darlinghurst
NSW 2010
Country 5980 0
Australia
Phone 5980 0
+61 2 8382 3438
Fax 5980 0
+61 2 8382 2090
Email 5980 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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