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Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00405171
First received: November 27, 2006
Last updated: October 27, 2010
Last verified: October 2010
History of Changes
  Purpose

Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.


Condition Intervention Phase
HIV Infections
Hypercholesterolemia
Antiretroviral Therapy
 Drug: Nevirapine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Decrease in LDL cholesterol between baseline and week 52

Estimated Enrollment: 40
Study Start Date: June 2003
Estimated Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months
  • plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions 14 days apart
  • Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) >3.4 mmol/L in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age>45 among males or age>55 among females, hypertension, current smoking, family history of CHD
  • Low-Density Lipoprotein cholesterol (LDL-c)>4.1 mmol/L regardless of CHD risk factors.

Exclusion Criteria:

  • Protease inhibitors use within the previous 6 months,
  • Prior exposure to nevirapine
  • Asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
  • AST or ALT>1.25N if hepatitis virus B or C were positive
  • Fasting glycemia>1.26g/L,
  • Current CHD
  • Triglycerides>4.6 mmol/L
  • Introduction of lipid lowering drugs, corticoïds, retinoïds and betablockers within the previous 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405171

Locations
France
Côte de Nacre University hospital
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
Boehringer Ingelheim Pharmaceuticals
Investigators
Principal Investigator: Jean-Jacques Parienti, MD University Hospital, Caen
Study Chair: Renaud Verdon, MD, PhD Côte de Nacre
  More Information

Additional Information:
Publication  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00405171     History of Changes
Other Study ID Numbers: SIROCCO
Study First Received: November 27, 2006
Last Updated: October 27, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Caen:
Efavirenz
Nevirapine
Dyslipidemia
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hypercholesterolemia
Dyslipidemias
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
Hyperlipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Nevirapine
Efavirenz
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013