Prospective Evaluation of Etravirine for HIV-infected Patients in Need of Lipid-lowering Drugs (ETRALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01543035
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : December 12, 2013
Janssen-Cilag A.G., Switzerland
Information provided by (Responsible Party):
Calmy Alexandra, University Hospital, Geneva

Brief Summary:

Dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein (LDL) cholesterol and reduced high-density lipoprotein (HDL) cholesterol levels, is common in HIV-infected individuals, and has been associated with HIV infection itself and antiretroviral therapy (ART). These abnormalities are well-established markers of cardiovascular (CVD) risk in the general population. Studies have suggested an increased risk of CVD associated with ART exposure over and above that conveyed by traditional cardiovascular risk factors. In HIV population to reduce lipid parameters, the most usual clinical strategy remains to add a statin treatment.

Recent studies suggested ART switch can represent an interesting alternative to statins to reduce lipid plasma levels.

The purpose of this study is to evaluate the frequency with which the replacement of LPV/r (lopinavir/ritonavir), ATZ/r (atazanavir/ritonavir), DRV/r (darunavir/ritonavir) or EFV (efavirenz) by ETR (Etravirin) in dyslipidemic patients with suppressed viremia would obviate the necessity to administer statins.

A prospective, phase III study in which the statin treatment of dyslipidemic HIV patients on antiretroviral drugs (ARVs) will be interrupted during 4 weeks is proposed.

At week 4, patients qualifying for a lipid lowering drug (calculated LDL-C≥ 3mmol/L) will replace EFV, LPV/r, DRV/r or ATZ/r by ETR. The proportion of patients not qualifying anymore for a statin treatment at 12 weeks (i.e. after 8 weeks of ETR treatment) will be determined. Additionally, the lipid level changes will be assessed at 12 weeks. Inflammatory markers will be measured at baseline, at drug switch and at the end of the study

Study drug will be provided by the drug manufacturer (Janssen-Cilag, AG). Compliance for study drug will be done at week-4 and week-12, Returned study medication will be counted and the amount notified on the Case Report Form (CRF).

Condition or disease Intervention/treatment Phase
HIV Infection Drug: stop statin and switch to an antiretroviral drug with less impact on lipid metabolism Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Prospective Multicentric Trial Evaluating Etravirine for HIV Infected Patients in Need of Lipid Lowering Drugs: the ETRALL Trial
Study Start Date : December 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Etravirine

Arm Intervention/treatment
Experimental: Etravirine switch
Patients in need of lipid-lowering drug switched from boosted PI or EFV to Etravirine
Drug: stop statin and switch to an antiretroviral drug with less impact on lipid metabolism
Switch from a boosted PI or efavirenz based ART regimen to etravirine 400 mg/day once daily for patients in need of lipid lowering drugs (statin) after one month wash out of statin

Primary Outcome Measures :
  1. Proportion of patients not qualifying anymore for statin treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. fasting lipids changes [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • On statin treatment for at least 3 months (fluvastatin, simvastatin, pravastatin, rosuvastatin, or atorvastatin) for primary prevention of cardiovascular disease
  • HIV Ribonucleic Acid (RNA) below 50 copies/mL, minimum duration 3 months
  • On a stable (> 3 months) ARV treatment including at least one of the following drugs: LPV/r, ATZ/r, DRV/r, or EFV
  • No previous virological escape or virological escape documented with a genotype at the time of failure only showing a K103M mutation.

Exclusion Criteria:

  • Probability of cardiovascular complications of > 20% according to the Swiss GSLA ("Groupe de travail Lipide et Athérosclérose"/Swiss Atherosclerosis Association) guidelines
  • Previous cardiovascular disease (including stroke)
  • Known diabetes
  • Known intolerance of ETR
  • Presence of a documented drug mutation (excluding the K103M)
  • Regimen including non-boosted ATZ
  • Known hyperlipidemia before ARV initiation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01543035

Universitätsspital Basel Klinik für Infektiologie & Spitalhygiene
Bale, Switzerland, 4031
Inselspital PKT2B / Poliklinik für Infektiologie
Berne, Switzerland, 3010
HUG /Division des Maladies infectieuses Unité VIH/SIDA
Geneva, Switzerland, 1211
Hôpital Neuchâtelois - La Chaux-de-Fonds Service des Maladies infectieuses
La Chaux-de-Fonds, Switzerland, 2300
CHUV / Service des maladies infectieuses Médecine 2
Lausanne, Switzerland, 1011
Kantonsspital / Infektiologie und Spitalhygiene Departement Innere Medizin
St Gallen, Switzerland, 9007
Universitätsspital Zürich Division of Infectious Diseases and Hospital Epidemiology Department of Internal Medicine
Zurich, Switzerland, 8091
Sponsors and Collaborators
Calmy Alexandra
Janssen-Cilag A.G., Switzerland
Principal Investigator: Calmy Alexandra, Md, PhD University Hospital, Geneva


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Calmy Alexandra, MD, PhD, HIV department Director, University Hospital, Geneva Identifier: NCT01543035     History of Changes
Other Study ID Numbers: ETRALL DR3215
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

Keywords provided by Calmy Alexandra, University Hospital, Geneva:
HIV infection
lipid lowering drugs
statin treatment
EFV or boosted PI antiretroviral treatment

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Antiviral Agents
Anti-Infective Agents
Anticholesteremic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors