Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juan A. Arnaiz
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Germans Trias i Pujol Hospital; Hospital Universitari Joan XXIII de Tarragona.; Hospitales Universitarios Virgen del Rocío
• Treatments: Efavirenz; Emtricitabine; Lopinavir; Ritonavir; Tenofovir

Criteria

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