HIV Infection
Conditions
Keywords
HIV infection, lipid lowering drugs, etravirine, patient, statin treatment, EFV or boosted PI antiretroviral treatment
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).
Interventions
DRUGstop 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
Sponsors
Janssen-Cilag A.G., Switzerland
Calmy Alexandra
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients not qualifying anymore for statin treatment | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| fasting lipids changes | 12 weeks |
Countries
Switzerland
Outcome results
None listed