NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients (NU-TRY(HIV))

March 21, 2018 updated by: Matteo Pirro, University Of Perugia

Lipid-lowering and Vascular Effects of a Nutraceutical Combination in HIV-infected Patients on Stable Antiretroviral Therapy

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 arterial stiffness were investigated in human immunodeficiency virus (HIV)-infected patients receiving stable antiretroviral therapy (ART).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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-week lipid stabilization period with a standardized diet regimen, the effect of a 3-month oral NC containing red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg vs no active treatment (noNC) was tested on plasma total cholesterol (TC), LDL-C, high density lipoprotein cholesterol (HDL-C), triglyceride, lipoprotein(a), PCSK9, high-sensitivity C-reactive protein (hsCRP) levels and aortic pulse wave velocity (aPWV).

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • LDL-C >100 mg/dL
  • no history of cardiovascular disease
  • stable ART for at least 6 months

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutraceutical combination (NC)
Patients on standardized diet regimen taking a NC (red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg) one pill/day for 3 months
Dietary supplement: Nutraceutical combination (NC)
An oral NC (red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg) one pill/day was administered for 3 months along with prosecution of standardized diet regimen
Other Names:
  • Armolipid Plus, Meda Pharma - Mylan
Active Comparator: No nutraceutical combination (noNC)
Patients on standardized diet regimen without taking any NC
Behavioral: No nutraceutical combination (noNC)
Prosecution of standardized diet regimen for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in LDL-C levels at 3 months
Time Frame: 3 months after treatment randomization
plasma LDL-C levels
3 months after treatment randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in PCSK9 levels at 3 months
Time Frame: 3 months after treatment randomization
plasma PCSK9 levels
3 months after treatment randomization
Change from baseline in subclinical inflammation at 3 months
Time Frame: 3 months after treatment randomization
plasma hs-CRP levels
3 months after treatment randomization
Change from baseline in arterial stiffness at 3 months
Time Frame: 3 months after treatment randomization
aPWV
3 months after treatment randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in creatine phosphokinase (CPK) levels at 3 months
Time Frame: 3 months after treatment randomization
plasma CPK levels
3 months after treatment randomization
Change from baseline in aspartate transaminase (AST) levels at 3 months
Time Frame: 3 months after treatment randomization
plasma AST levels
3 months after treatment randomization
Change from baseline in alanine transaminase (ALT) levels at 3 months
Time Frame: 3 months after treatment randomization
plasma ALT levels
3 months after treatment randomization
Change from baseline in CD4+ cell count at 3 months
Time Frame: 3 months after treatment randomization
CD4+ cell count
3 months after treatment randomization
Change from baseline in HIV-1 RNA levels at 3 months
Time Frame: 3 months after treatment randomization
HIV-1 RNA levels
3 months after treatment randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Investigators

  • Principal Investigator: Matteo Pirro, M.D., PhD, University of Perugia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2017

Primary Completion (Actual)

November 15, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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