Prospective Evaluation of Etravirine for HIV-infected Patients in Need of Lipid-lowering Drugs
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
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).