Pravastatin for Hyperlipidaemia in HIV.
A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV
2 other identifiers
interventional
40
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hiv-infections
Started Jul 2001
Typical duration for phase_4 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 27, 2005
CompletedFirst Posted
Study publicly available on registry
September 28, 2005
CompletedJune 9, 2006
June 1, 2006
September 27, 2005
June 8, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Between-group difference in time weighted change from baseline in fasting serum total cholesterol
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
- The University of New South Walescollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Garvan Institute of Medical Researchcollaborator
- St Vincent's Hospital, Sydneycollaborator
Study Sites (1)
St. Vincents Hospital
Sydney, New South Wales, 2010, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew D Carr, MD
National Centre in HIV Epidemiology and Clinical Research.
- STUDY DIRECTOR
David A Cooper, MD
National Centre in HIV Epidemiology and Clinical Research.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 27, 2005
First Posted
September 28, 2005
Study Start
July 1, 2001
Study Completion
October 1, 2004
Last Updated
June 9, 2006
Record last verified: 2006-06