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Pravastatin and Protease Inhibitors in HIV-infected Patients

CompletedPhase 2

Sponsor: University Hospital, Bordeaux

Conditions: HIV Infection, Hypercholesterolemia

Interventions: Pravastatin (drug), Placebo

Countries: France

To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* Current AIDS event or infectious disease
* Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
* Psychiatric conditions
* Biological elevated muscular enzymes
* Chronic alcohol consumption
* Pregnancy

Locations (1)

Bordeaux, France