Prospective Evaluation of Etravirine for HIV-infected Patients in Need of Lipid-lowering Drugs (ETRALL)
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|ClinicalTrials.gov Identifier: NCT01543035|
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : December 12, 2013
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)|
|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|
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
- Proportion of patients not qualifying anymore for statin treatment [ Time Frame: 12 weeks ]
- fasting lipids changes [ Time Frame: 12 weeks ]
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 ClinicalTrials.gov 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|
|Principal Investigator:||Calmy Alexandra, Md, PhD||University Hospital, Geneva|