Status:
COMPLETED
Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
HIV Infections
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00405171
Start Date
June 1 2003
End Date
February 1 2006
Last Update
October 28 2010
Active Locations (1)
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1
Côte de Nacre University hospital
Caen, France, 14033