Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000307303
Ethics application status
Approved
Date submitted
4/04/2007
Date registered
30/06/2008
Date last updated
22/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, controlled comparison of uridine, pravastatin or uridine plus pravastatin to accelerate recovery of lipoatrophy in Human immunodeficiency virus (HIV)-infected adults
Scientific title
A randomised, controlled comparison of uridine, pravastatin or uridine plus pravastatin to accelerate recovery of lipoatrophy in Human immunodeficiency virus (HIV)-infected adults
Secondary ID [1] 587 0
Nil
Universal Trial Number (UTN)
Trial acronym
URISTAT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 2143 0
lipoatrophy 2144 0
Condition category
Condition code
Infection 2240 2240 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, controlled comparison of uridine 36g three times a day for the first 10 days of each month , pravastatin 40 mg daily or uridine 36g three times a day for the first 10 days of each month plus pravastatin 40 mg daily to accelerate recovery of lipoatrophy in HIV-infected adults. Both drugs are taken orally for 24 weeks
Intervention code [1] 1689 0
Treatment: Drugs
Comparator / control treatment
Human immunodeficiency virus (HIV)-infected adults with lipoatrophy on kaletra (2 x 200mg/50mg tablets, orally 2 times a day for 24 weeks) containing regimen of anti retrovirals
Control group
Active

Outcomes
Primary outcome [1] 4383 0
Difference in changes in limb fat mass Dual-Energy X-ray Absorptiometry (DEXA)
Timepoint [1] 4383 0
Weeks 4, 16, 28
Secondary outcome [1] 5197 0
Safety ( clinical, chemistry, haematology) and tolerability. Specific indicators are complete blood count, biochemistry including Liver function tests, blood urea and electrolytes, lactate, amylase, creatinine kinase. Indicators for tolerability are treatment adherence rate, incidence of adverse events as reported by participants at regular study visits (weeks 2,4,5 8,16,28)
Timepoint [1] 5197 0
weeks 0, 2,4,5 8,16,28
Secondary outcome [2] 5198 0
Intra-abdominal fat area(VAT) and subcutaneous visceral fat area (SAT) measured by 3-slice computerised tomography (CT) scan at the lumbar (L)2-3,L3-4 and L4-5 vertebral levels
Measured by 3-slice CT scan
Timepoint [2] 5198 0
weeks 4 and 28
Secondary outcome [3] 5199 0
fasting lipids (total, non-high density lipid (HDL) and low density lipid (LDL) cholestrol , triglycerides). Measured by blood sample analysis
Timepoint [3] 5199 0
at screening visit, weeks 0, 4, 8, 16 and 28
Secondary outcome [4] 5200 0
fasting glucose, insulin and estimated insulin resistance (HOMA) Measured by blood sample analysis
Timepoint [4] 5200 0
at screening visit, weeks 4, 8, 16 and 28
Secondary outcome [5] 5201 0
lactate Measured by blood sample analysis
Timepoint [5] 5201 0
at screening visit, weeks 0, 4, 8, 16 and 28
Secondary outcome [6] 5202 0
HIV viral load
Measured by blood sample analysis
Timepoint [6] 5202 0
at screening visit, weeks 0, 4, 16 and 28
Secondary outcome [7] 5203 0
Mitochondrial function in peripheral blood monocytes. Measured by blood sample analysis
Timepoint [7] 5203 0
Weeks 4 and 16

Eligibility
Key inclusion criteria
1. subcutaneous lipoatrophy in at least 2 body sites, at least one of which is moderate or severe according to both the patient and the doctor
2. HIV viral load <50 copies /ml plasma for at least 3 months
3. use of stable HARRT not including tNRTI for at least 3 months
4. no grade 3or 4 laboratory values at baseline
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. zidovudine (AZT) or stavudine (d4T) in preceding 12 weeks (12/52)
2. ongoing opportunistic infection , other AIDS -defining illness or other illness that would interfere with participation
3. clinically significant renal or hepatic disease
4.lipid levels necessitating statin treatment
5. anabolic steriods, growth hormone, or supra-physiological corticosteriod doeses.
6. pregnancy or breast feeding
7. allergy to any component of the randomised drugs
8. prior use of uridine

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)
allocation involved contacting the holder of the allocation schedule who was off site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
28/11/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2398 0
Commercial sector/Industry
Name [1] 2398 0
Abbott
Country [1] 2398 0
Australia
Funding source category [2] 3509 0
Hospital
Name [2] 3509 0
St Vincent's Hospital, Sydney
Country [2] 3509 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital , Sydney
Address
390 Victoria St
Darlinghurst, NSW 2010
Australia
Country
Australia
Secondary sponsor category [1] 2173 0
None
Name [1] 2173 0
Address [1] 2173 0
Country [1] 2173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4231 0
St Vincent's Hospital, Sydney
Ethics committee address [1] 4231 0
390 Victoria St Darlinghurst, NSW 2010 Australia
Ethics committee country [1] 4231 0
Australia
Date submitted for ethics approval [1] 4231 0
Approval date [1] 4231 0
15/05/2006
Ethics approval number [1] 4231 0
H06/026

Summary
Brief summary
Prospective, randomised, 28-week trial in 40 patients.
The first step: forty (40) eligible, consented participants will switch from existing PI or NNRTI and commence ritonavir-boosted lopinavir at week 0 (2 tablets twice-daily).
The second step: patients on lopinavir/r will be randomised to initiate study therapy at week 4 (4 weeks after initiation of lopinavir/r) for 24 weeks.
Eligible subjects will be randomised equally (10 patients per group) to:
1. uridine (36g tid for 10 days per month)
2. pravastatin (40 mg nocte)
3. uridine (36g tid for 10 days per month) + pravastatin (40 mg nocte)
4. delayed treatment arm (DTA)
All patients will be offered the combination of pravastatin and uridine for 24 weeks from week 28.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27792 0
Prof Andrew Carr
Address 27792 0
St Vincents Hospital
Xavier, Level 4
390 Victoria St
Darlinghurst
NSW 2010
Country 27792 0
Australia
Phone 27792 0
+61 2 8382 3359
Fax 27792 0
Email 27792 0
acarr@stvincents.com.au
Contact person for public queries
Name 10878 0
Ms Robyn Richardson
Address 10878 0
St Vincent's Hospital
HIV Clinical Trials Unit
Xavier 4
390 Victoria Street
Darlinghurst NSW 2010
Country 10878 0
Australia
Phone 10878 0
02 83823872
Fax 10878 0
02 83822090
Email 10878 0
rrichardson1@stvincents.com.au
Contact person for scientific queries
Name 1806 0
Prof Professor Andrew Carr
Address 1806 0
St Vincent's Hospital
HIV Clinical Trials Unit
Xavier 4
390 Victoria Street
Darlinghurst NSW 2010
Country 1806 0
Australia
Phone 1806 0
020 8382 3438
Fax 1806 0
02 8382 3489
Email 1806 0
acarr@stvincents.com.au

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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