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ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART (NILACH)

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ClinicalTrials.gov Identifier: NCT01683656
Recruitment Status : Terminated (Withdrawal of IMP from the market. Data on risk-benefit ratio pending.)
First Posted : September 12, 2012
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
University Hospital, Geneva
Swiss National Science Foundation
Fondation Ernest Boninchi
Swiss Heart Foundation
Information provided by (Responsible Party):
Calmy Alexandra, University Hospital, Geneva

Study Description
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Brief Summary:

HIV-infected patients are at increased risk for cardiovascular disease. Large investigations support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only through its benefit in terms of lipid profile, but also by reducing atherosclerotic inflammation.

The study aims at showing that a therapy targeting HDL-C increase in HIV-infected patients on suppressive cART has the potential for reducing subclinical atherosclerotic inflammation associated with HIV itself in HIV-individuals on cART.

NILACH is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to test the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness (IMT) in 90 subjects.

  • Regimen 1: ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5 to the end of the study (the titration aims to reduce adverse reactions)
  • Regimen 2: ER niacin/laropiprant placebo p.m.

The primary end point is the change in mean common carotid intima-media thickness from baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group.

The proposed in vivo experiments should provide insights on the potential benefits of niacin treatment of cardiovascular disease in HIV patients. In addition, we will be able to further clarify the role of systemic inflammatory mediators in the development of early atherosclerosis of HIV-infected patients on antiretroviral therapy. Detection and treatment of non-infectious co-morbidities such as cardiovascular diseases have become essential for HIV-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere management of opportunistic infections or virologic suppression.


Condition or disease Intervention/treatment Phase
HIV Atherosclerosis Drug: niacin/laropiprant Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART
Study Start Date : August 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ER Niacin/laropipant
ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5 to the end of the study.
 Drug: niacin/laropiprant
Other Name: Tredaptive
Placebo Comparator: ER Niacin/laropipant Placebo
ER niacin/laropiprant placebo p.m.
 Drug: Placebo
Procedures for the manufacturing and testing of the placebo are compiled in the IMP/study drug dossier and comply with local regulatory requirements (by GMP certified manufacturer).


Outcome Measures
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Primary Outcome Measures :
  1. change in mean common carotid intima-media thickness [ Time Frame: 48 weeks ]
    mean of maximal IMT value will be calculated over three cardiac cycles and for left and right carotid artery at baseline and week 48. The primary endpoint will be assessed by a single investigator in a blinded and anonymized fashion at cIMT Core Facility, Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada Responsible: Pr Jean-Claude Tardif.


Secondary Outcome Measures :
  1. Mean hs-CRP plasma concentration changes [ Time Frame: 12, 24, 48 weeks ]
  2. Mean Total Cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, apolipoprotein, triglycerides, and apolipoprotein (apo) Al, B and E levels [ Time Frame: 12, 24, 48 weeks ]
  3. Mean biomarkers of inflammatory process (fibrinogen, S-VCAM-1, adiponectin, CCL2, CCL3, d-dimer, IL-6, TNF-alpha, Lp-PLA2) changes [ Time Frame: 12, 24, 48 weeks ]
  4. Clinical MACE: cardiovascular mortality, stroke, acute coronary syndromes, any cardiac arrhythmias, hospitalisation for cardiovascular causes, peripheral artery disease, revascularization. [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients > 40 years;
  • Women of childbearing potential must use two reliable contraceptive methods during the entire trial, from day 1 to one month after the end of the trial.
  • Signing the study consent form;
  • Stable cART since at least 3 months (ie no recent drug change);
  • HIV-RNA below 100 copies for at least 6 months;
  • HDL-cholesterol <1.29 mmol/l for men; <1.42 mmol/l for women

Exclusion Criteria:

  • Pregnancy or lactation;
  • Congestive Heart Failure;
  • Malignant Hypertension;
  • Acute or chronic coronary artery diseases;
  • Any known cardiac arrhythmias;
  • Diabetes;
  • Concomitant cancer, rheumatologic disease or inflammatory bowel diseases;

  • Concomitant renal or hepatic disease:

    • Creatinine above 150 micromol/L
    • Transaminases above 5 times upper normal limit
    • Prothrombin time (Quick) value below 50%;
  • Prior intolerance to niacin therapy (reported in a medical report);
  • Cyclosporine, anti-inflammatory drugs (other than aspirin) or cytokine therapy in concomitant intake;
  • Abnormal thyroid function;
  • Excessive consumption of alcohol;
  • Known severe lactose intolerance.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01683656


Locations
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Switzerland
University Hospital Berne Inselspital
Berne, BE, Switzerland, 3010
University Hospital Basel
Basel, BS, Switzerland, 4031
University Hospitals Genève
Geneva, GE, Switzerland, 1211
Kantonsspital St Gallen
St Gallen, SG, Switzerland, 9007
EOC Ente Ospedaliero Cantonale, civico
Lugano, TI, Switzerland, 6903
CHUV Cantonal University Hospital Vaud
Lausanne, VD, Switzerland, 1011
University Hospital Zurich
Zurich, ZH, Switzerland
Sponsors and Collaborators
Calmy Alexandra
University Hospital, Geneva
Swiss National Science Foundation
Fondation Ernest Boninchi
Swiss Heart Foundation
Investigators
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Principal Investigator: Alexandra Calmy, MD University Hospital, Geneva
More Information
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Publications:

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Responsible Party: Calmy Alexandra, Head of HIV Unit, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01683656    
Other Study ID Numbers: NILACH 2012DR4097
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Keywords provided by Calmy Alexandra, University Hospital, Geneva:
HIV
Atherosclerosis
Niacin/laropiprant
HDL
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Niacin
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs