Status:
COMPLETED
Pravastatin and Protease Inhibitors in HIV-Infected Patients
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Conditions:
HIV Infection
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.
Detailed Description
Background. Highly Active AntiRetroviral Therapy including protease inhibitors is associated with elevated plasma lipid levels. Design. randomized double-blind, multicentric. Intervention. Pravastat...
Eligibility Criteria
Inclusion
- confirmed HIV-1 infection (ELISA confirmed by Western-Blot test) ;
- Age above 18 years
- Stable antiretroviral therapy including at least one PI for \>= 3 months,
- Plasma HIV-RNA level of \< 50 copies/mL for \>= 3 months before randomization,
- Total cholesterol \> = 5.5 mmol/L with LDL-cholesterol \> = 3.4 mmol/L on fasting status after three months of standardized dietary advice,
- signed informed consent
Exclusion
- Current AIDS event or infectious disease
- Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
- Psychiatric conditions
- Biological elevated muscular enzymes
- Chronic alcohol consumption
- Pregnancy
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00221754
Start Date
March 1 2003
End Date
March 1 2004
Last Update
June 13 2007
Active Locations (1)
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1
Hôpital Saint André, Service de médecine interne et maladies infectieuses
Bordeaux, France, 33000