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

This study has been completed.
Sponsor:
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

February 27, 2012
December 11, 2013
December 2011
July 2013   (final data collection date for primary outcome measure)
Proportion of patients not qualifying anymore for statin treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01543035 on ClinicalTrials.gov Archive Site
fasting lipids changes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prospective Evaluation of Etravirine for HIV-infected Patients in Need of Lipid-lowering Drugs
Phase III Prospective Multicentric Trial Evaluating Etravirine for HIV Infected Patients in Need of Lipid Lowering Drugs: the ETRALL Trial

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).

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
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
Experimental: Etravirine switch
Patients in need of lipid-lowering drug switched from boosted PI or EFV to Etravirine
Intervention: Drug: stop statin and switch to an antiretroviral drug with less impact on lipid metabolism

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
August 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01543035
ETRALL DR3215
No
Calmy Alexandra, University Hospital, Geneva
Calmy Alexandra
Janssen-Cilag A.G., Switzerland
Principal Investigator: Calmy Alexandra, Md, PhD Geneva University Hospital
University Hospital, Geneva
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP