AzTrials
AzTrials

HIV-1 InfectionPhase 2NCT01426438

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

A Phase 2 study testing Niacin, Aspirin and Fenofibrate in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
Niacin, Aspirin and Fenofibrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
14 sitesUnited States
Study dates
Nov 2011to Oct 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 28Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Colorado Hospital CRS (6101)

    Aurora, Colorado, 80045

  • Alabama Therapeutics CRS (5801)

    Birmingham, Alabama, 35294

  • Unc Aids Crs (3201)

    Chapel Hill, North Carolina, 27516

  • Northwestern University CRS (2701)

    Chicago, Illinois, 60611

  • Univ. of Cincinnati CRS (2401)

    Cincinnati, Ohio, 45267

  • Case CRS (2501)

    Cleveland, Ohio, 44106

  • Duke Univ. Med. Ctr. Adult CRS (1601)

    Durham, North Carolina, 27710

  • Moses H. Cone Memorial Hospital CRS (3203)

    Greensboro, North Carolina, 27401

  • University of Southern California (1201)

    Los Angeles, California, 90033-1079

  • UCLA CARE Center CRS (601)

    Los Angeles, California, 90095

  • NY Univ. HIV/AIDS CRS (401)

    New York, New York, 10016

  • New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477)

    Newark, New Jersey, 07103

  • University of Washington AIDS CRS (1401)

    Seattle, Washington, 98104

  • Harbor-UCLA Med. Ctr. CRS (603)

    Torrance, California, 90502

Other trials in United States

About this study

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

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

Conditions
HIV-1 Infection
Being tested
Niacin, Aspirin, Fenofibrate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiacinDrug

    Extended-release niacin will be given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)

  • AspirinDrug

    Aspirin 325 mg will be given by mouth in the evening with extended-release niacin through week 24.

  • FenofibrateDrug

    Fenofibrate will be administered as 200 mg by mouth once daily for 24 weeks.

Study groups in NCT01426438
Study groupRoleWhat they receive
Arm A: Extended-release niacin with aspirinExperimentalNot described
Receives: Drug: Niacin; Drug: Aspirin
Arm B: FenofibrateExperimentalNot described
Receives: Drug: Fenofibrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Change in Relative FMD (%)

    The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.

    Measured: 0 and 24 weeks

Secondary outcomes (13)

  1. Change in Cholesterol

    Absolute change in total cholesterol from week 0 to week 24.

    Measured: 0 and 24 weeks

  2. Change in Triglycerides

    Change in Triglycerides (mg/dL) from week 0 to week 24.

    Measured: 0 and 24 weeks

  3. Men: Change in HDL Cholesterol

    Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24.

    Measured: 0 and 24 weeks

  4. Women: Change in HDL Cholesterol

    Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24.

    Measured: 0 and 24 weeks

  5. Change in HDL Particles

    Change in total HDL particles from week 0 to week 24

    Measured: 0 and 24 weeks

  6. Change in Non-HDL Cholesterol

    Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24.

    Measured: 0 and 24 weeks

  7. Change in LDL Cholesterol

    Change in LDL cholesterol (mg/dL) from week 0 to week 24.

    Measured: 0 and 24 weeks

  8. Change in Small LDL Particles

    Change in Small LDL particles from week 0 to week 24.

    Measured: 0 and 24 weeks

  9. Change in Large HDL Particles

    Change in Large HDL Particles from week 0 to week 24

    Measured: 0 and 24 weeks

  10. Change in HOMA-IR

    Absolute change from week 0 to week 24 in insulin resistance as estimated by HOMA-IR

    Measured: 0 and 24 weeks

  11. Change in IL-6

    Change in IL-6 from week 0 to week 24

    Measured: 0 and 24 weeks

  12. Change in C-reactive Protein (CRP)

    Change in C-reactive protein from week 0 to week 24.

    Measured: 0 and 24 weeks

  13. Change in D-Dimer

    Change in D-Dimer from week 0 to week 24

    Measured: 0 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01426438
Sponsor's protocol ID
ACTG A5293
Other IDs
1U01AI068636
Status last verified
Jan 2016
First submitted
30 Aug 2011
Last updated
3 Feb 2016
Data monitoring committee
Yes

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.

  • Dube MP, Chan ES, Lake JE, Williams B, Kinslow J, Landay A, Coombs RW, Floris-Moore M, Ribaudo HJ, Yarasheski KE. A Randomized, Double-blinded, Placebo-controlled Trial of Sitagliptin for Reducing Inflammation and Immune Activation in Treated and Suppressed Human Immunodeficiency Virus Infection. Clin Infect Dis. 2019 Sep 13;69(7):1165-1172. doi: 10.1093/cid/ciy1051.

    PubMed 30535188

  • Dube MP, Komarow L, Fichtenbaum CJ, Cadden JJ, Overton ET, Hodis HN, Currier JS, Stein JH; AIDS Clinical Trials Group A5293 Study Team. Extended-Release Niacin Versus Fenofibrate in HIV-Infected Participants With Low High-Density Lipoprotein Cholesterol: Effects on Endothelial Function, Lipoproteins, and Inflammation. Clin Infect Dis. 2015 Sep 1;61(5):840-9. doi: 10.1093/cid/civ385. Epub 2015 May 15.

    PubMed 25979307

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niacin, Aspirin and Fenofibrate in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change in Relative FMD (%) (time frame: 0 and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01426438, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in