Status:
COMPLETED
Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 prob...
Eligibility Criteria
Inclusion
- 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
- 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 entry.
- 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, Naprosyn).
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01426438
Start Date
November 1 2011
End Date
October 1 2013
Last Update
February 3 2016
Active Locations (14)
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1
Alabama Therapeutics CRS (5801)
Birmingham, Alabama, United States, 35294
2
University of Southern California (1201)
Los Angeles, California, United States, 90033-1079
3
UCLA CARE Center CRS (601)
Los Angeles, California, United States, 90095
4
Harbor-UCLA Med. Ctr. CRS (603)
Torrance, California, United States, 90502