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Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate

Information source: AIDS Clinical Trials Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

Intervention: Niacin (Drug); Aspirin (Drug); Fenofibrate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AIDS Clinical Trials Group

Official(s) and/or principal investigator(s):
Michael P Dube, MD, Study Chair, Affiliation: University of Southern California
James H Stein, MD, Study Chair, Affiliation: University of Wisconsin School of Medicine and Public Health (Northwestern University CRS)


This study is being done with people with HIV infection who have low levels of HDL-C. HDL-C is a type of "good" cholesterol. People with low HDL-C have a higher risk of heart disease and may have problems with how their blood vessels relax. The endothelium is the inner lining of all blood vessels, such as arteries and veins. When the endothelium is not working properly, the blood vessels have trouble expanding properly, which contributes to the development of heart and blood vessel disease. The main purpose of this study is to see if taking either extended-release niacin or fenofibrate for 24 weeks will help blood vessels work better by improving endothelial function and increasing HDL-C. Niacin and fenofibrate are medications that raise HDL-C. This study will also help determine how safe extended-release niacin and fenofibrate are. The analysis is an as-treated analysis of participants who completed study treatment and had a week 24 BART scan. Safety analyses include all participants

Clinical Details

Official title: Effect of HDL-Raising Therapies on Endothelial Function, Lipoproteins, and Inflammation in HIV-infected Subjects With Low HDL Cholesterol: A Phase II Randomized Trial of Extended Release Niacin vs. Fenofibrate

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Absolute Change in Relative FMD (%)

Secondary outcome:

Change in Cholesterol

Change in Triglycerides

Men: Change in HDL Cholesterol

Women: Change in HDL Cholesterol

Change in HDL Particles

Change in Non-HDL Cholesterol

Change in LDL Cholesterol

Change in Small LDL Particles

Change in Large HDL Particles

Change in HOMA-IR

Change in IL-6

Change in C-reactive Protein (CRP)

Change in D-Dimer


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- HIV-1 infection

- Currently on continuous ART for ≥48 weeks.

- CD4+ cell count ≥100/mm3 obtained within 60 days prior to study entry.

- Most recent HIV-1 RNA below the limit of detection using an ultrasensitive licensed

or FDA-approved assay obtained within 60 days prior to study entry.

- Certain laboratory values obtained within 60 days prior to study entry (as indicated

in the protocol).

- HDL-C ≤ 40 mg/dL for men or ≤ 50 mg/dL for women within 60 days prior to study entry

by any local assay.

- Fasting triglycerides 150-800 mg/dL within 60 days prior to study entry, (initially

200-800 mg/dL, amended during study conduct).

- LDL-C < 160 mg/dL within 60 days prior to study entry.

- For women of reproductive potential, negative serum or urine pregnancy test with a

sensitivity of 15-25 mIU/mL within 60 days prior to entry.

- Female subjects of reproductive potential must agree to use a reliable method of

contraception while receiving study drug and for 6 weeks after stopping study drug. Exclusion Criteria:

- Anticipation of changing ART.

- Intent to initiate or change the dose of lipid-lowering drugs or antihypertensives

during study.

- Active acute infection or other serious illness requiring systemic treatment and/or

hospitalization until subject either completes or is clinically stable on therapy in the opinion of the site investigator.

- Untreated hypogonadism

- History of physician-diagnosed diabetes mellitus or currently taking glucose-lowering

medication, (amended during study conduct to allow well-controlled diabetics who are diet controlled or on stable antidiabetic treatment of metformin, sulfonylurea, meglitinides or alpha-glucosidase inhibitors).

- Hormonal anabolic therapies within 90 days prior to study entry.

- Uncontrolled hypertension within 60 days of study entry.

- Acute symptoms of gout within 60 days prior to study entry.

- Active peptic ulcer disease as defined by a health care professional. Treatment for

gastroesophageal reflux disease (GERD) is not exclusionary.

- Documented untreated hypothyroidism per subject's medical records.

- Use of thyroid hormone supplements other than for treatment of hypothyroidism within

30 days prior to entry.

- Active or symptomatic gallbladder disease within 1 year of study entry.

- Active cancer requiring systemic chemotherapy or radiation within 1 year of study


- Lipid-lowering agents within 30 days prior to study entry.

- Use of fish oil with DHA/EPA >1000 mg/day within 30 days prior to entry.

- Niacin or niacin-containing products that contain >100 mg daily within 30 days prior

to study entry.

- Use of vitamin E supplements greater than 200 IU/day within 30 days prior to entry.

- Use of vitamin C supplements greater than 250 mg/day within 30 days prior to entry.

- Use of systemic cancer chemotherapy, immunomodulators (e. g., growth factors, immune

globulin, interleukins, and interferons) within 90 days prior to study entry.

- Any systemic glucocorticoid above replacement levels, defined as the equivalent of ≥

7. 5 mg of prednisone daily, within 60 days prior to study entry.

- Allergy, sensitivity, or severe intolerance to both aspirin and naproxen (Aleve,


- Symptomatic pancreatitis with hospitalization.

- Pregnancy or currently breastfeeding.

- Active drug or alcohol use or dependence that, in the opinion of the site

investigator, would interfere with adherence to study requirements.

- Currently taking or anticipation of starting medication during the study for

hepatitis C including interferon and ribavirin.

- Documented history of macular edema.

- Current severe congestive heart failure (New York Heart Association [NYHA] Class III

or IV).

- History of or current diagnosis of coronary artery disease, angina pectoris,

myocardial infarction, previous coronary artery intervention (stenting, angioplasty), peripheral arterial disease (claudication, peripheral arterial angioplasty, or peripheral arterial bypass procedure), cerebrovascular disease (stroke or transient ischemic attack with documented carotid or aortic atherosclerosis), or abdominal aortic aneurysm.

Locations and Contacts

Alabama Therapeutics CRS (5801), Birmingham, Alabama 35294, United States

UCLA CARE Center CRS (601), Los Angeles, California 90095, United States

University of Southern California (1201), Los Angeles, California 90033-1079, United States

Harbor-UCLA Med. Ctr. CRS (603), Torrance, California 90502, United States

University of Colorado Hospital CRS (6101), Aurora, Colorado 80045, United States

Northwestern University CRS (2701), Chicago, Illinois 60611, United States

New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477), Newark, New Jersey 07103, United States

NY Univ. HIV/AIDS CRS (401), New York, New York 10016, United States

Unc Aids Crs (3201), Chapel Hill, North Carolina 27516, United States

Duke Univ. Med. Ctr. Adult CRS (1601), Durham, North Carolina 27710, United States

Moses H. Cone Memorial Hospital CRS (3203), Greensboro, North Carolina 27401, United States

Univ. of Cincinnati CRS (2401), Cincinnati, Ohio 45267, United States

Case CRS (2501), Cleveland, Ohio 44106, United States

University of Washington AIDS CRS (1401), Seattle, Washington 98104, United States

Additional Information

Related publications:

International Conference on Harmonisation. E2A: Clinical Safety Data Management : Definitions and Standards for Expedited Reporting. Website: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-safety-data-management-definitions-and-standards-for-expedited-reporting.html. Accessed May 24, 2011.

Starting date: November 2011
Last updated: November 19, 2014

Page last updated: August 23, 2015

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