Pravastatin and Protease Inhibitors in HIV-Infected Patients

Hypercholesterolemia Clinical Trial

Official title:

Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221754
• Other study ID #: 9268-02
• Secondary ID: 2001-026
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 12, 2007
• Start date: March 2003
• Est. completion date: March 2004

Study information

• Verified date: June 2007
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• Hypercholesterolemia

Intervention

Drug:
• Pravastatin (drug)

Locations

Country	Name	City	State
France	Hôpital Saint André, Service de médecine interne et maladies infectieuses	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV RNA		at 12 weeks
Secondary	Lipid biological markers
Secondary	Plasma level of protease inhibitors
Secondary	CD4 count at 12 weeks
Secondary	Safety