Status:
COMPLETED
NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients
Lead Sponsor:
University Of Perugia
Conditions:
Hypercholesterolemia
Inflammation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The effects of a nutraceutical combination (NC) containing low-dose monacolin K and berberine on lipid profile, proprotein convertase subtilisin/kexin type 9 (PCSK9), subclinical inflammation and arte...
Detailed Description
This is a crossover interventional study of 26 HIV-infected patients on stable ART with low density lipoprotein cholesterol (LDL-C) \>100 mg/dL, not receiving any lipid-lowering treatment. After a 3-w...
Eligibility Criteria
Inclusion
- LDL-C \>100 mg/dL
- no history of cardiovascular disease
- stable ART for at least 6 months
Exclusion
- current or recent (≤6 months) treatment with lipid-lowering drugs
- chronic kidney disease \[estimated glomerular filtration rate (GFR) \<60 ml/min\]
- liver impairment (AST and/or ALT \>3 times upper limit of normal)
- current pregnancy
- opportunistic infections within the past 3 months,
- having received an organ transplant/immunosuppressive therapy
Key Trial Info
Start Date :
January 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03470376
Start Date
January 15 2017
End Date
November 30 2017
Last Update
March 23 2018
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