Pravastatin for Hyperlipidaemia in HIV.

Phase 4

Completed

Conditions: HIV
Lipid metabolism
Glucose metabolism
Metabolic abnormality
Lipodystrophy
Cardiovascular disease
Infection - Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular - Other cardiovascular diseases

Registration Number: ACTRN12605000663651

Lead Sponsor: The University of New South Wales

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The between-group difference in time weighted change from baseline in fasting serum total cholesterol.[]

Secondary Outcome Measures

Name	Time	Method
i. between-group difference in time weighted change from week 4 in fasting serum total cholesterol (start of pravastatin).[];ii. individual changes in fasting total cholesterol at each measured time point.[];iii. between-group difference in time weighted change from baseline in HDL-cholesterol and triglycerides, change from baseline glucose, insulin.[];iv. between-group difference in change from baseline in total and regional body fat.[];v. between-group difference in change from baseline in endothelial function and peripheral blood markers of cardiovascular risk.[]