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

Primary Purpose

HIV Infections, Hypercholesterolemia, Antiretroviral Therapy

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Nevirapine
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Efavirenz, Nevirapine, Dyslipidemia, HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Côte de Nacre University hospital

Outcomes

Primary Outcome Measures

Decrease in LDL cholesterol between baseline and week 52

Secondary Outcome Measures

Full Information

First Posted
November 27, 2006
Last Updated
October 27, 2010
Sponsor
University Hospital, Caen
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00405171
Brief Title
Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia
Official Title
Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Caen
Collaborators
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hypercholesterolemia, Antiretroviral Therapy
Keywords
Efavirenz, Nevirapine, Dyslipidemia, HIV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nevirapine
Primary Outcome Measure Information:
Title
Decrease in LDL cholesterol between baseline and week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Parienti, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renaud Verdon, MD, PhD
Organizational Affiliation
Côte de Nacre
Official's Role
Study Chair
Facility Information:
Facility Name
Côte de Nacre University hospital
City
Caen
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20433360
Citation
Parienti JJ, Peytavin G, Reliquet V, Verdon R, Coquerel A. Pharmacokinetics of the treatment switch from efavirenz to nevirapine. Clin Infect Dis. 2010 Jun 1;50(11):1547-8. doi: 10.1086/652718. No abstract available.
Results Reference
background
PubMed Identifier
17578790
Citation
Parienti JJ, Massari V, Rey D, Poubeau P, Verdon R; SIROCCO study team. Efavirenz to nevirapine switch in HIV-1-infected patients with dyslipidemia: a randomized, controlled study. Clin Infect Dis. 2007 Jul 15;45(2):263-6. doi: 10.1086/518973. Epub 2007 Jun 6.
Results Reference
result

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

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