Antiretroviral Therapy, HIV Infections, Hypercholesterolemia
Conditions
Keywords
Efavirenz, Nevirapine, Dyslipidemia, HIV
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.
Interventions
DRUGNevirapine
Sponsors
Boehringer Ingelheim
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in LDL cholesterol between baseline and week 52 | — |
Countries
France
Outcome results
None listed