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Completed

NCT Number: NCT00405171

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Côte de Nacre University hospital

Caen, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nevirapine

Drug

Primary outcomes

  1. Decrease in LDL cholesterol between baseline and week 52

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Nov 29, 2006
Registry last updated
Oct 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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