Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism

Phase 4

• Conditions: HIV Infections
• Interventions: Drug: Tenofovir + emtricitabine + efavirenz; Drug: Tenofovir + emtricitabine + lopinavir/ritonavir

• Registration Number: NCT00759070
• Lead Sponsor: Juan A. Arnaiz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-22
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tenofovir + emtricitabine + efavirenz	Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
2	Tenofovir + emtricitabine + lopinavir/ritonavir	Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)

Primary Outcome Measures

Name	Time	Method
Changes in total cholesterol and HDL and LDL fractions	48 weeks

Trial Locations

Locations (5)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Joan XXIII; 🇪🇸 Tarragona, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain