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

Phase 4

Completed

• Conditions: Hypercholesterolemia; Antiretroviral Therapy; HIV Infections

• Registration Number: NCT00405171
• Lead Sponsor: University Hospital, Caen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2006-02
• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-29
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-27
• Last Update Posted: 2010-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decrease in LDL cholesterol between baseline and week 52

Trial Locations

Locations (1)

Côte de Nacre University hospital; 🇫🇷 Caen, France