Prospective Evaluation of Etravirine for HIV-infected Patients in Need of Lipid-lowering Drugs (ETRALL)
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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, ATZ/r, DRV/r or EFV by ETR 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 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 ECF.
| 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: 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 CER11-128 |
- Proportion of patients not qualifying anymore for statin treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- fasting lipids changes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | March 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 OD for patients in need of lipid lowering drugs (statin)after one month wash out of statin
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
- HIVRNA 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 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| Contact: Calmy Alexandra, Md, PhD | +41 22 372 98 12 | alexandra.calmy@hcuge.ch |
| Contact: Ciaffi Laura, MD | +41 79 55 32 888 | laura.ciaffi@hcuge.ch |
| Switzerland | |
| Universitätsspital Basel Klinik für Infektiologie & Spitalhygiene | Recruiting |
| Bale, Switzerland, 4031 | |
| Contact: Stoeckle Marcel, MD +41 61 328 66 35 stoecklem@uhbs.ch | |
| Principal Investigator: Stoeckle Marcel, MD | |
| Inselspital PKT2B / Poliklinik für Infektiologie | Recruiting |
| Berne, Switzerland, 3010 | |
| Contact: Wandeler Gilles, MD +41 31 632 15 74 gilles.wandeler@insel.ch | |
| Principal Investigator: Wandeler Gilles, MD | |
| HUG /Division des Maladies infectieuses Unité VIH/SIDA | Recruiting |
| Geneva, Switzerland, 1211 | |
| Contact: Calmy Alexandra, MD, PhD +41 22 372 98 12 alexandra.calmy@hcuge.ch | |
| Sub-Investigator: Ciaffi Laura, MD | |
| Hôpital Neuchâtelois - La Chaux-de-Fonds Service des Maladies infectieuses | Recruiting |
| La Chaux-de-Fonds, Switzerland, 2300 | |
| Contact: Genne Daniel, MD +41 32 967 21 11 daniel.genne@ne.ch | |
| Principal Investigator: Genne Daniel, MD | |
| CHUV / Service des maladies infectieuses Médecine 2 | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Cavassini Matthias, MD +41 21 314 1022 matthias.cavassini@chuv.ch | |
| Sub-Investigator: Clerc Olivier, MD | |
| Kantonsspital / Infektiologie und Spitalhygiene Departement Innere Medizin | Recruiting |
| St Gallen, Switzerland, 9007 | |
| Contact: Schmid Patrick, MD +41 71 494 10 21 patrick.schmid@kssg.ch | |
| Principal Investigator: Schmid Patrick, MD | |
| Universitätsspital Zürich Division of Infectious Diseases and Hospital Epidemiology Department of Internal Medicine | Recruiting |
| Zurich, Switzerland, 8091 | |
| Contact: Fehr Jan, MD +41 44 255 38 26 Jan.fehr@usz.ch | |
| Principal Investigator: Fehr Jan, MD | |
| Principal Investigator: | Calmy Alexandra, Md, PhD | Geneva University Hospital |
More Information
Publications:
| 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: | September 5, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University Hospital, Geneva:
|
HIV infection Lipidlowering drugs etravirine |
Patient statin treatment EFV or boosted PI antiretroviral treatment |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Hypolipidemic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013