Pravastatin and Protease Inhibitors in HIV-Infected Patients

Phase 2

Completed

• Conditions: HIV Infection; Hypercholesterolemia

• Registration Number: NCT00221754
• Lead Sponsor: University Hospital, Bordeaux

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. 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

Study Timeline

• Study Start: 2003-03
• Study Completion: 2004-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-12
• Last Update Posted: 2007-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HIV RNA	at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Lipid biological markers
Plasma level of protease inhibitors
CD4 count at 12 weeks
Safety

Trial Locations

Locations (1)

Hôpital Saint André, Service de médecine interne et maladies infectieuses; 🇫🇷 Bordeaux, France