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Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01258439
Ethics application status
Date submitted
9/12/2010
Date registered
10/12/2010
Date last updated
8/01/2015

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 - Fasting samples will be taken for total cholesterol, LDL and HDL cholesterol, and triglycerides. Repeat lipid samples will be collected before a high fat meal is consumed. After the meal is completed , blood will be collected at 1, 2, 3, and 4 hours at baseline, week 4 and week 24 visits.
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
safety - Safety parameters will be assessed by measurement of urea and electrolytes, LFTs, urine protein to creatinine ratio
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Other metabolic parameters - Fasting metabolic parameters will be assessed. Study staff and participants will be blinded to the results fo these tests until completion of the study or parameters become sginificantly abnormal
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a research study into the effects of three drugs used to treat HIV infection. Some
drugs used to treat HIV have been associated with changes in blood fats such as cholesterol
that could be harmful over the long-term, because these blood fat changes have been
associated with a small, increased risk of heart disease and stroke in some studies of adults
with HIV. Now that HIV can be controlled for long periods in most patients, and because heart
disease is one of the biggest causes of illness and death in the general population, it is
important to develop new HIV treatments that control HIV effectively but do not cause
abnormal blood fats.

Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than
ritonavir-boosted darunavir.
Trial website
https://clinicaltrials.gov/show/NCT01258439
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