Phase 2
N=99
Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT01426438 ↗Enrolled (actual)
99
Serious AEs
1.0%
Results posted
Oct 2014
Primary outcome: Primary: Absolute Change in Relative FMD (%) — 0.60; 0.50 % FMD — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Niacin (Drug); Aspirin (Drug); Fenofibrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Relative FMD (%) |
0.60; 0.50 | 0.28 |
| SECONDARY Change in Cholesterol |
-9; -2 | — |
| SECONDARY Change in Triglycerides |
-65; -54 | — |
| SECONDARY Men: Change in HDL Cholesterol |
3; 6.5 | — |
| SECONDARY Women: Change in HDL Cholesterol |
16; 8 | — |
| SECONDARY Change in HDL Particles |
-1.7; 4.3 | — |
| SECONDARY Change in Non-HDL Cholesterol |
-17; -4 | — |
| SECONDARY Change in LDL Cholesterol |
-1; 7 | — |
| SECONDARY Change in Small LDL Particles |
-176; -119 | — |
| SECONDARY Change in Large HDL Particles |
0.9; -0.3 | — |
| SECONDARY Change in HOMA-IR |
1.3; 0.3 | — |
| SECONDARY Change in IL-6 |
0.1; 0.2 | — |
| SECONDARY Change in C-reactive Protein (CRP) |
-0.6; 0.7 | — |
| SECONDARY Change in D-Dimer |
0.06; 0.06 | — |
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 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
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01426438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.