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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Calmy Alexandra

Collaborator
Janssen-Cilag A.G., Switzerland

Information provided by (Responsible Party)
Calmy Alexandra, University Hospital, Geneva

ClinicalTrials.gov Identifier
NCT01543035

First received: February 27, 2012
Last updated: December 11, 2013
Last Verified: December 2013
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infection

Drug : stop statin and switch to an antiretroviral drug with less impact on lipid metabolism
Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Calmy Alexandra, University Hospital, Geneva:

Primary Outcome Measures

  • Proportion of patients not qualifying anymore for statin treatment [ Time Frame: 12 weeks ]
Secondary Outcome Measures:
  • fasting lipids changes [ Time Frame: 12 weeks ]

Enrollment: 34
Study Start Date: December 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 70 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543035

Locations

Switzerland
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

Investigators

Principal Investigator: Calmy Alexandra, Md, PhD Geneva University Hospital
More Information

More Information


Responsible Party: Calmy Alexandra, MD, PhD, HIV department Director, University Hospital, Geneva  
ClinicalTrials.gov Identifier: NCT01543035   History of Changes  
Other Study ID Numbers: ETRALL DR3215  
Study First Received: February 27, 2012  
Last Updated: December 11, 2013  

Keywords provided by Calmy Alexandra, University Hospital, Geneva:

HIV infection
lipid lowering drugs
etravirine
patient
statin treatment
EFV or boosted PI antiretroviral treatment

Additional relevant MeSH terms:
HIV Infections
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Etravirine
Hypolipidemic Agents

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.