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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections Hypercholesterolemia Antiretroviral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Nevirapine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jean-Jacques Parienti, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Renaud Verdon, MD, PhD

Role: STUDY_CHAIR

Côte de Nacre

Locations

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Côte de Nacre University hospital

Caen, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND

PMID: 20433360 (View on PubMed)

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.

Reference Type RESULT

PMID: 17578790 (View on PubMed)

Other Identifiers

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SIROCCO

Identifier Type: -

Identifier Source: org_study_id