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

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT00759070
First received: September 23, 2008
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
HIV Infections
Drug: Tenofovir + emtricitabine + efavirenz
Drug: Tenofovir + emtricitabine + lopinavir/ritonavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Changes in total cholesterol and HDL and LDL fractions [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759070

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Clinic
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
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

No publications provided

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
Study First Received: September 23, 2008
Last Updated: February 21, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Treatment Naïve

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Tenofovir
Tenofovir disoproxil
Efavirenz
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014