Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00227500




Registration number
NCT00227500
Ethics application status
Date submitted
27/09/2005
Date registered
28/09/2005
Date last updated
9/06/2006

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] 0 0
PRAVA / RO1 HL65953-01
Secondary ID [2] 0 0
PRAVA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Lipid Metabolism 0 0
Glucose Metabolism 0 0
Metabolic Abnormality 0 0
Lipodystrophy 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pravastatin

Treatment: Drugs: Pravastatin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Between-group difference in time weighted change from baseline in fasting serum total cholesterol
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Includes: between-group difference in time weighted change: from wk 4 in fasting serum total cholesterol as well as from baseline in HDL-cholesterol and triglycerides; in total and regional body fat; in endothelial function
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Provide written informed consent to participate in the trial

- HIV-1 sero-positive

- Male/female >18 years age

- 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
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any condition which may interfere with ability to comply with study

- 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 patient's 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking 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
1/07/2001
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
St. Vincents Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Garvan Institute of Medical Research
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
St Vincent's Hospital, Sydney
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/ct2/show/NCT00227500
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew D Carr, MD
Address 0 0
National Centre in HIV Epidemiology and Clinical Research.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00227500