Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia

Caen University Hospital

Status and phase

Completed

Phase 4

Conditions

Hypercholesterolemia

Antiretroviral Therapy

HIV Infections

Treatments

Drug: Nevirapine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00405171

SIROCCO

Details and patient eligibility

About

Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months
plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions 14 days apart
Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) >3.4 mmol/L in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age>45 among males or age>55 among females, hypertension, current smoking, family history of CHD
Low-Density Lipoprotein cholesterol (LDL-c)>4.1 mmol/L regardless of CHD risk factors.

Exclusion criteria

Protease inhibitors use within the previous 6 months,
Prior exposure to nevirapine
Asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
AST or ALT>1.25N if hepatitis virus B or C were positive
Fasting glycemia>1.26g/L,
Current CHD
Triglycerides>4.6 mmol/L
Introduction of lipid lowering drugs, corticoïds, retinoïds and betablockers within the previous 3 months.