Pravastatin for Hyperlipidaemia in HIV.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00227500
• Date of registration: 27/09/2005
• Prospective Registration: No
• Primary sponsor: Kirby Institute
• 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
• Date of first enrolment: July 2001
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00227500
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Andrew D Carr, MD
• Affiliation: National Centre in HIV Epidemiology and Clinical Research

• Name: David A Cooper, MD
• Affiliation: National Centre in HIV Epidemiology and Clinical Research

Key inclusion & exclusion criteria

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)

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular Disease

Glucose Metabolism

Metabolic Abnormality

HIV Infections

Lipodystrophy

Lipid Metabolism

Intervention(s)

Drug: Pravastatin

Primary Outcome(s)

Between-group difference in time weighted change from baseline in fasting serum total cholesterol

Secondary Outcome(s)

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

Secondary ID(s)

PRAVA

PRAVA / RO1 HL65953-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Garvan Institute of Medical Research

National Heart, Lung, and Blood Institute (NHLBI)

St Vincent's Hospital, Sydney

The University of New South Wales