None listed
Conditions
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.
Interventions
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.
Sponsors
The University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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)
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.
Outcome results
None listed