This trial is active, not recruiting.

Condition hiv infections
Treatments tenofovir + emtricitabine + efavirenz, tenofovir + emtricitabine + lopinavir/ritonavir
Phase phase 4
Sponsor Juan A. Arnaiz
Collaborator Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Start date September 2008
End date July 2013
Trial size 50 participants
Trial identifier NCT00759070, EudraCT number: 2007-002698-29, LIPOTAR-07


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
tenofovir + emtricitabine + efavirenz
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences) + Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily
(Active Comparator)
Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)
tenofovir + emtricitabine + lopinavir/ritonavir
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID

Primary Outcomes

Changes in total cholesterol and HDL and LDL fractions
time frame: 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Hospital Clinic of Barcelona.