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

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ClinicalTrials.gov Identifier: NCT00759070
Recruitment Status : Unknown
Verified February 2013 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2008
Last Update Posted : February 22, 2013
Sponsor:
Collaborators:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Germans Trias i Pujol Hospital
Hospital Universitari Joan XXIII de Tarragona.
Hospitales Universitarios Virgen del Rocío
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Tenofovir + emtricitabine + efavirenz Drug: Tenofovir + emtricitabine + lopinavir/ritonavir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects
Study Start Date : September 2008
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
 Drug: Tenofovir + emtricitabine + efavirenz

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

+ Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily
Active Comparator: 2
Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)
 Drug: Tenofovir + emtricitabine + lopinavir/ritonavir
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID


Outcome Measures
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Primary Outcome Measures :
  1. Changes in total cholesterol and HDL and LDL fractions [ Time Frame: 48 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759070


Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clinic
Barcelona, Spain, 08036
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Hospital Joan XXIII
Tarragona, Spain, 43007
Sponsors and Collaborators
Juan A. Arnaiz
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Germans Trias i Pujol Hospital
Hospital Universitari Joan XXIII de Tarragona.
Hospitales Universitarios Virgen del Rocío
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00759070     History of Changes
Other Study ID Numbers: LIPOTAR-07
EudraCT number: 2007-002698-29
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
Treatment Naïve

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Tenofovir
Emtricitabine
Efavirenz
HIV Protease Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers