Status:
COMPLETED
Pravastatin for Hyperlipidaemia in HIV.
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
The University of New South Wales
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
HIV Infections
Lipid Metabolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Detailed Description
High serum cholesterol concentrations are commonly seen in HIV-infected patients treated with some protease inhibitor medications as part of long-term antiretroviral therapy for HIV. There is concern ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00227500
Start Date
July 1 2001
End Date
October 1 2004
Last Update
June 9 2006
Active Locations (1)
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1
St. Vincents Hospital
Sydney, New South Wales, Australia, 2010