Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism

Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects

This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.

Inclusion Criteria:

• Chronic HIV-1 infection
• Age 18 or above
• Antiretroviral-naive
• Criteria for antiretroviral therapy in accordance with current guidelines
• Plasma LDL-cholesterol below 190 mg/dL
• Not receiving lipid-lowering agents
• Written informed consent

Exclusion Criteria:

• Use of phytosterol-enriched food previous month.
• Pregnancy or breastfeeding
• Cardiovascular disease
• Secondary Hypercholesterolemia
• Plasma creatinine above 1,2 mg/dL)
• Aminotransferases above 5 times ULN
• Current treatment for hepatitis C coinfection
• Diabetes mellitus (fasting glycemia > 124 mg/dL)
• Illegal drug use or alcohol abuse
• Active AIDS-defining opportunistic disease