Pravastatin and Protease Inhibitors in HIV-Infected Patients

University Hospital of Bordeaux

Status and phase

Completed

Phase 2

Conditions

Hypercholesterolemia

HIV Infection

Treatments

Drug: Pravastatin (drug)

Study type

Interventional

Funder types

Other

Identifiers

NCT00221754

2001-026

9268-02

Details and patient eligibility

About

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

Full description

Background. Highly Active AntiRetroviral Therapy including protease inhibitors is associated with elevated plasma lipid levels.

Design. randomized double-blind, multicentric.

Intervention. Pravastatin versus placebo for 12 weeks.

Eligibility criteria. Positive for anti-VIH antibodies, 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, written informed consent

Outcomes. HIV RNA at 12 weeks

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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