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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01258439




Registration number
NCT01258439
Ethics application status
Date submitted
9/12/2010
Date registered
13/12/2010
Date last updated
12/01/2015

Titles & IDs
Public title
Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.
Scientific title
Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir-boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)-Naive Adults or Adults Recommencing ART.
Secondary ID [1] 0 0
ROaR+
Universal Trial Number (UTN)
Trial acronym
ROaR+
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - raltegravir plus truvada
Treatment: Drugs - Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)

Active comparator: 1.Raltegravir plus truvada - Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks

Active comparator: 2. ritonavir boosted darunavir plus truvada - Darunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks


Treatment: Drugs: raltegravir plus truvada
raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks

Treatment: Drugs: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
Darunavir two 400mg tablets with one ritonavir 100mg capsule once daily plus Tenofovir/emtricitabine (Truvada) one 300mg/200mg tablet once daily with food for 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
safety
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Other metabolic parameters
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Arterial stiffness
Timepoint [3] 0 0
24 weeks

Eligibility
Key inclusion criteria
* Provision of signed, informed consent
* Age >18 years
* HIV infection documented by HIV antibody test and Western Blot prior to study entry
* No previous ART OR no ART for 6 months prior to randomisation
* CD4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
* No genotypic resistance to Raltegravir, Tenofovir/emtricitabine, Darunavir, Ritonavir
* Body mass index less than 30kg/m2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary HIV infection within the last 6 months
* Active infection or opportunistic illness within the previous 30 days
* Use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
* Use of lipid-lowering therapy
* Diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
* Use of oral prednisolone > 7.5mg daily or equivalent
* pregnancy or Breast feeding
* proven hypersensitivity to one or more components of the study meal

Study design
Purpose of the study
Treatment
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [2] 0 0
St Vincent Hospital, Clinical Research Program - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital, Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew D Carr, Professor
Address 0 0
St Vincent's Hospital - Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01258439