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Trial registered on ANZCTR


Registration number
ACTRN12605000663651
Ethics application status
Approved
Date submitted
27/09/2005
Date registered
19/10/2005
Date last updated
19/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pravastatin for Hyperlipidaemia in HIV.
Scientific title
A Randomised, Double-blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients with HIV
Secondary ID [1] 198 0
National Heart, Lung, and Blood Institute of the National Institutes of Health: R01 HL65953-01
Universal Trial Number (UTN)
Trial acronym
PRAVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV
806 0
Lipid metabolism 807 0
Glucose metabolism 808 0
Metabolic abnormality 809 0
Lipodystrophy 810 0
Cardiovascular disease 811 0
Condition category
Condition code
Infection 874 874 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular 875 875 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised, placebo-controlled study of the effect of 12 weeks treatment with the HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated patients with high serum cholesterol. We hypothesise that pravastatin will result in greater reductions in cholesterol than placebo when used in conjunction with appropriate dietary advice.
Intervention code [1] 682 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1122 0
The between-group difference in time weighted change from baseline in fasting serum total cholesterol.
Timepoint [1] 1122 0
Secondary outcome [1] 2076 0
i. between-group difference in time weighted change from week 4 in fasting serum total cholesterol (start of pravastatin).
Timepoint [1] 2076 0
Secondary outcome [2] 2077 0
ii. individual changes in fasting total cholesterol at each measured time point.
Timepoint [2] 2077 0
Secondary outcome [3] 2078 0
iii. between-group difference in time weighted change from baseline in HDL-cholesterol and triglycerides, change from baseline glucose, insulin.
Timepoint [3] 2078 0
Secondary outcome [4] 2079 0
iv. between-group difference in change from baseline in total and regional body fat.
Timepoint [4] 2079 0
Secondary outcome [5] 2080 0
v. between-group difference in change from baseline in endothelial function and peripheral blood markers of cardiovascular risk.
Timepoint [5] 2080 0

Eligibility
Key inclusion criteria
Provide written informed consent to participate in the trial - HIV-1 sero-positive - Currently receiving HIV protease inhibitor therapy for > 12 weeks and unlikely to require change in existing regimen during the 16 week study period- Fasting cholesterol > 6.5 mmol/L (mean of 2 samples collected > 3 days apart)
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gastrointestinal disorder which may affect drug absorption- Hypertension or congestive cardiac failure- Lactic acidemia (serum lactate level >2.2 mmol/L)- Any serious medical condition which may compromise the patients safety, including pancreatitis or hepatitis within past 6 months- Active AIDS defining conditions- Concurrent therapy with any other lipid lowering agents, oral hypoglycaemics, anabolic steroids or insulin.

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)
Subjects were randomised on a 1:1 ratio to either active drug or matched placebo. Randomisation was performed by the hospital pharmacy and the study investigators were blinded as to randomised allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence was generated by the study statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 963 0
Government body
Name [1] 963 0
National Heart Lung and Blood Institute
Address [1] 963 0
Country [1] 963 0
United States of America
Funding source category [2] 964 0
Government body
Name [2] 964 0
US National Institutes of Health
Address [2] 964 0
Country [2] 964 0
United States of America
Primary sponsor type
University
Name
The University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 833 0
Hospital
Name [1] 833 0
St Vincents Hospital
Address [1] 833 0
Country [1] 833 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2262 0
St Vincent's Hospital, Sydney Limited
Ethics committee address [1] 2262 0
Ethics committee country [1] 2262 0
Australia
Date submitted for ethics approval [1] 2262 0
Approval date [1] 2262 0
Ethics approval number [1] 2262 0

Summary
Brief summary
This study is a randomised, placebo-controlled study of the effect of treatment with the HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated patients with high serum cholesterol. We hypothesise that pravastatin will result in greater reductions in cholesterol than placebo when used in conjunction with appropriate dietary advice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35376 0
Address 35376 0
Country 35376 0
Phone 35376 0
Fax 35376 0
Email 35376 0
Contact person for public queries
Name 9871 0
Andrew D Carr
Address 9871 0
National Centre in HIV Epidemiology and Clinical Research (NCHECR)
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 9871 0
Australia
Phone 9871 0
+61 2 83823359
Fax 9871 0
+61 2 83822893
Email 9871 0
acarr@stvincents.com.au
Contact person for scientific queries
Name 799 0
Patrick WG Mallon
Address 799 0
National Centre in HIV Epidemiology and Clinical Research (NCHECR)
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 799 0
Australia
Phone 799 0
+61 2 83823107
Fax 799 0
+61 2 83822391
Email 799 0
pmallon@nchecr.unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary