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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00405171
First Posted: November 29, 2006
Last Update Posted: October 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boehringer Ingelheim
Information provided by:
University Hospital, Caen
November 27, 2006
November 29, 2006
October 28, 2010
June 2003
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Decrease in LDL cholesterol between baseline and week 52
Same as current
Complete list of historical versions of study NCT00405171 on ClinicalTrials.gov Archive Site
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Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia
Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • HIV Infections
  • Hypercholesterolemia
  • Antiretroviral Therapy
Drug: Nevirapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2006
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00405171
SIROCCO
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University Hospital, Caen
Boehringer Ingelheim
Principal Investigator: Jean-Jacques Parienti, MD University Hospital, Caen
Study Chair: Renaud Verdon, MD, PhD Côte de Nacre
University Hospital, Caen
October 2010

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