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

HIV Infections Clinical Trial

Official title:

Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405171
• Other study ID #: SIROCCO
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2006
• Last updated: October 27, 2010
• Start date: June 2003
• Est. completion date: February 2006

Study information

• Verified date: October 2010
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antiretroviral Therapy
• Dyslipidemias
• HIV Infections
• Hypercholesterolemia

Intervention

Drug:
• Nevirapine

Locations

Country	Name	City	State
France	Côte de Nacre University hospital	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Boehringer Ingelheim

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Epub 2007 Jun 6. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in LDL cholesterol between baseline and week 52