Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Tenofovir + emtricitabine + efavirenz

Intervention Type DRUG

Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)

\+ Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily

2

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

Group Type ACTIVE_COMPARATOR

Tenofovir + emtricitabine + lopinavir/ritonavir

Intervention Type DRUG

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

Interventions

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Tenofovir + emtricitabine + efavirenz

Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)

\+ Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily

Intervention Type DRUG

Tenofovir + emtricitabine + lopinavir/ritonavir

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No