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

NCT00405171 | Completed Phase 4

• 1 other identifier: SIROCCO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Hypercholesterolemia; Antiretroviral Therapy

Keywords

Efavirenz; Nevirapine; Dyslipidemia; HIV

Outcome Measures

Primary Outcomes (1)

• Decrease in LDL cholesterol between baseline and week 52

Interventions

Nevirapine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Côte de Nacre University hospital

Caen, 14033, France

Location

Related Publications (2)

• 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.

  PMID: 20433360 BACKGROUND

• 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.

  PMID: 17578790 RESULT

MeSH Terms

Conditions

HIV Infections; Hypercholesterolemia; Dyslipidemias

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jean-Jacques Parienti, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

• Renaud Verdon, MD, PhD

  Côte de Nacre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 29, 2006
• Study Start: June 1, 2003
• Study Completion: February 1, 2006
• Last Updated: October 28, 2010

Record last verified: 2010-10

Locations

FR (1)