Trial | NCT00759070  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
Study Started
Sep 30
2008
Primary Completion
Jul 31
2013
Anticipated
Study Completion
Jul 31
2013
Anticipated
Last Update
Feb 22
2013
Estimate

Drug Tenofovir + emtricitabine + efavirenz

Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences) + Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily

Drug Tenofovir + emtricitabine + lopinavir/ritonavir

Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID

1 Active Comparator

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

2 Active Comparator

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

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
No Results Posted