Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism (LIPOTAR-07)

Juan A. Arnaiz

Status and phase: Unknown; Phase 4

Conditions: HIV Infections

Treatments: Drug: Tenofovir + emtricitabine + lopinavir/ritonavir; Drug: Tenofovir + emtricitabine + efavirenz

Study type: Interventional

Funder types: Other

Identifiers

NCT00759070

LIPOTAR-07

EudraCT number: 2007-002698-29

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)

Treatment:

Drug: Tenofovir + emtricitabine + efavirenz

2

Active Comparator group

Description:

Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)

Treatment:

Drug: Tenofovir + emtricitabine + lopinavir/ritonavir