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

September 23, 2008
February 21, 2013
September 2008
July 2013   (final data collection date for primary outcome measure)
Changes in total cholesterol and HDL and LDL fractions [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00759070 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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
  • Active Comparator: 1
    Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
    Intervention: Drug: Tenofovir + emtricitabine + efavirenz
  • Active Comparator: 2
    Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)
    Intervention: Drug: Tenofovir + emtricitabine + lopinavir/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00759070
LIPOTAR-07, EudraCT number: 2007-002698-29
No
Juan A. Arnaiz, Hospital Clinic of Barcelona
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
Not Provided
Hospital Clinic of Barcelona
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP