Cardiovascular DiseasesHeartPositiveNCT00246376

Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia

A study testing Diet, Exercise and Niacin in people with Cardiovascular Diseases and Heart Diseases, run by Baylor College of Medicine at 1 site 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 will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cardiovascular Diseases, Heart Diseases, HIV Infections
What is being tested?: Diet, Exercise and Niacin
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 221 participants
Where: 1 siteUnited States
Study dates: Jan 2004to Feb 2012
Phase: Interventional
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV positive
On stable HAART regimen for at least 6 months prior to study entry
T-cell count greater than 100 and viral load less than 1,000 for at least 6 months prior to study entry
Fasting triglyceride level greater than 150 mg/dl
Body mass index (BMI) greater than 18.5 and less than 30
Uses barrier contraception

Who cannot join

Fasting triglyceride level greater than 1000 mg/dl
BMI less than 18.5 or greater than 30
Taking diabetic medication or HbA1c less than 7.0
Use of lipid lowering medication in the 30 days prior to study entry
Unable to exercise
T-cell count less than 100

Show all 32Show fewer

Current medical condition that makes exercise unadvisable
History of coronary artery disease (CAD)
Use of dietary supplements (within 30 days of study entry) that may affect lipid levels including, but not limited to, the following:
Omega-3 fatty acids
L-Carnitine
Soluble fiber supplements
Guggul
Garlic supplements
Niacin greater than 25mg/d
Oral liquid supplements
Use of steroids, hormones, or testosterone (without diagnosis of hypogonadism, testosterone less than 300 ng/dl)
Irregular periods
Depo-Provera
Hypo- or Hyperthyroidism
Adrenal insufficiency
Serum alanine or aspartate aminotransferase level greater than 3 times the upper limit of normal
Alcohol abuse
Renal insufficiency (creatinine level greater than 1.5 mg/dl)
Coumadin therapy
Pregnancy
Peptic ulcer disease
Cholelithiasis
History of hyperuricemia
History of myositis or rhabdomyolysis
Known adverse reaction to niacin or fibrates
Hepatitis C therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Baylor College of Medicine
Houston, Texas, 77098

Other trials in United States

About this study

Official title: Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy

This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.

Read the detailed description

BACKGROUND:

HIV lipodystrophy syndrome is associated with both metabolic (e.g., dyslipidemia and insulin resistance) and anthropomorphic (e.g., lipoatrophy and central obesity) abnormalities. These defects are likely to predispose HIV patients on highly active antiretroviral therapy (HAART) to accelerated cardiovascular morbidity. Based on studies of key mechanisms of altered lipid kinetics in these patients, evidence that DE patterns of patients with HIV lipodystrophy are inadequate to manage cardiovascular risk factors, and current recommendations for treatment of atherosclerosis and insulin resistance, the following is hypothesized: 1) an intensive lifestyle intervention with DE will improve the plasma lipid profile, decrease visceral fat mass, and improve hormonal, metabolic, and lipoprotein markers associated with insulin resistance; and 2) adding niacin, fenofibrate, or a combination of the two drugs to the intensive lifestyle intervention will result in further improvement in the cardiovascular risk profile.

DESIGN NARRATIVE:

This randomized, placebo-controlled study of 200 hypertriglyceridemic HIV patients on stable HAART treatment has the following specific aims: 1) to compare the effects of usual care, intensive DE, DE plus niacin, DE plus fenofibrate, and DE plus niacin plus fenofibrate on fasting plasma lipid concentrations (primary endpoint); 2) to compare the effects of the five treatment protocols on body fat distribution; and 3) to compare the effects of the five treatment protocols on hormonal, lipoprotein, and metabolic markers of insulin resistance. The collaborative team has expertise in lipid and lipoprotein metabolism, innovative and effective diet modification programs, intensive exercise programs in HIV patients, and studies of antilipidemic and antiretroviral agents. Therefore, this study will determine the efficacy of DE, with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.

Conditions: Cardiovascular Diseases, Heart Diseases, HIV Infections, Hyperlipidemia, Hypertriglyceridemia, Insulin Resistance
Being tested: Diet, Exercise, Niacin, Fenofibrate, Placebos
Medical subject headings: Cardiovascular Diseases, Heart Diseases, HIV Infections, Hyperlipidemias, Hypertriglyceridemia, Insulin Resistance, Atherosclerosis

What participants receive

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

DietBehavioural
ATP-III diet
ExerciseBehavioural
Supervised exercise in study gym
NiacinDrug
Niaspan, titrated up to 2 grams per day
FenofibrateDrug
Tricor, 120 mg per day
PlacebosOther
Placebos for Niaspan and Tricor

Study groups in NCT00246376
Study group	Role	What they receive
1	Placebo comparator	Subjects receive lifestyle advice and placebos for Niaspan and Tricor Receives: Other: Placebos
2	Experimental	Diet, exercise, and two placebos Receives: Behavioral: Diet; Behavioral: Exercise; Other: Placebos
3	Experimental	Diet, exercise, Niaspan, and placebo Receives: Behavioral: Diet; Behavioral: Exercise; Drug: Niacin; Other: Placebos
4	Experimental	Diet, exercise, placebo, and Tricor Receives: Behavioral: Diet; Behavioral: Exercise; Drug: Fenofibrate; Other: Placebos
5	Experimental	Diet, exercise, Niaspan, and Tricor Receives: Behavioral: Diet; Behavioral: Exercise; Drug: Niacin; Drug: Fenofibrate

What is being measured

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

Triglycerides
Triglycerides (mg/dL): Fasting lipid levels
Measured: Measured at 24 weeks
Non-HDL-C
non-HDL-C (mg/dL): Fasting lipid levels
Measured: Measured at 24 weeks
HDL-C
HDL-C (mg/dL): Fasting lipid levels
Measured: Measured at 24 weeks
Total Cholesterol
Total cholesterol (mg/dL): Fasting lipid levels
Measured: Measured at 24 weeks
Total Cholesterol : HDL-C Ratio
Total cholesterol : HDL-C ratio: Fasting lipid levels
Measured: Measured at 24 weeks

Secondary outcomes (2)

Insulin Sensitivity
Adiponectin (micrograms/ml)
Measured: Measured at 24 weeks
Body Composition
1. Body cell mass (kg)
2. Fat mass (kg)
Measured: Measured at 24 weeks

Timeline

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

Jan 2004Feb 2012

First posted31 Oct 2005 (estimated)
Study startJan 2004
Primary completionSep 2009
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00246376
Sponsor's protocol ID: H-14105
Other IDs: R01HL073696
Acronym: HeartPositive
Status last verified: Feb 2016
First submitted: 27 Oct 2005
Last updated: 21 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Samson SL, Pownall HJ, Scott LW, Ballantyne CM, Smith EO, Sekhar RV, Balasubramanyam A. Heart positive: design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/dyslipidemia. Contemp Clin Trials. 2006 Dec;27(6):518-30. doi: 10.1016/j.cct.2006.07.002. Epub 2006 Jul 21.
PubMed 16914390
Balasubramanyam A, Coraza I, Smith EO, Scott LW, Patel P, Iyer D, Taylor AA, Giordano TP, Sekhar RV, Clark P, Cuevas-Sanchez E, Kamble S, Ballantyne CM, Pownall HJ. Combination of niacin and fenofibrate with lifestyle changes improves dyslipidemia and hypoadiponectinemia in HIV patients on antiretroviral therapy: results of "heart positive," a randomized, controlled trial. J Clin Endocrinol Metab. 2011 Jul;96(7):2236-47. doi: 10.1210/jc.2010-3067. Epub 2011 May 11.
PubMed 21565796
Gillard BK, Raya JL, Ruiz-Esponda R, Iyer D, Coraza I, Balasubramanyam A, Pownall HJ. Impaired lipoprotein processing in HIV patients on antiretroviral therapy: aberrant high-density lipoprotein lipids, stability, and function. Arterioscler Thromb Vasc Biol. 2013 Jul;33(7):1714-21. doi: 10.1161/ATVBAHA.113.301538. Epub 2013 May 2.
PubMed 23640486
Vu CN, Ruiz-Esponda R, Yang E, Chang E, Gillard B, Pownall HJ, Hoogeveen RC, Coraza I, Balasubramanyam A. Altered relationship of plasma triglycerides to HDL cholesterol in patients with HIV/HAART-associated dyslipidemia: further evidence for a unique form of metabolic syndrome in HIV patients. Metabolism. 2013 Jul;62(7):1014-20. doi: 10.1016/j.metabol.2013.01.020. Epub 2013 Mar 19.
PubMed 23522788
Wooten JS, Nambi P, Gillard BK, Pownall HJ, Coraza I, Scott LW, Nambi V, Ballantyne CM, Balasubramanyam A. Intensive lifestyle modification reduces Lp-PLA2 in dyslipidemic HIV/HAART patients. Med Sci Sports Exerc. 2013 Jun;45(6):1043-50. doi: 10.1249/MSS.0b013e3182843961.
PubMed 23299761

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy
ClinicalTrials.gov ID: NCT00246376
Acronym / sponsor ID: HeartPositive / H-14105
Conditions: Cardiovascular Diseases, Heart Diseases, HIV Infections, Hyperlipidemia, Hypertriglyceridemia, Insulin Resistance
Study type: Interventional
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Legacy Community Health Center
Study start: Jan 2004
Primary completion: Sep 2009 (actual)
Study completion: Feb 2012 (actual)
First posted: 31 Oct 2005 (estimated)
Results: Posted 21 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.

Detailed description

BACKGROUND:

DESIGN NARRATIVE:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
1	Placebo comparator	Other: PlacebosSubjects receive lifestyle advice and placebos for Niaspan and Tricor
2	Experimental	Behavioral: Diet, Behavioral: Exercise, Other: PlacebosDiet, exercise, and two placebos
3	Experimental	Behavioral: Diet, Behavioral: Exercise, Drug: Niacin, Other: PlacebosDiet, exercise, Niaspan, and placebo
4	Experimental	Behavioral: Diet, Behavioral: Exercise, Drug: Fenofibrate, Other: PlacebosDiet, exercise, placebo, and Tricor
5	Experimental	Behavioral: Diet, Behavioral: Exercise, Drug: Niacin, Drug: FenofibrateDiet, exercise, Niaspan, and Tricor

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

HIV positive
On stable HAART regimen for at least 6 months prior to study entry
T-cell count greater than 100 and viral load less than 1,000 for at least 6 months prior to study entry
Fasting triglyceride level greater than 150 mg/dl
Body mass index (BMI) greater than 18.5 and less than 30

Key exclusion criteria (32 listed)

Fasting triglyceride level greater than 1000 mg/dl
BMI less than 18.5 or greater than 30
Taking diabetic medication or HbA1c less than 7.0
Use of lipid lowering medication in the 30 days prior to study entry
Unable to exercise

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DietATP-III diet	Behavioural	2, 3, 4, 5
ExerciseSupervised exercise in study gym	Behavioural	2, 3, 4, 5
NiacinNiaspan, titrated up to 2 grams per day	Drug	3, 5
FenofibrateTricor, 120 mg per day	Drug	4, 5
PlacebosPlacebos for Niaspan and Tricor	Other	1, 2, 3, 4

Primary outcome

Triglycerides
Time frame: Measured at 24 weeks
Triglycerides (mg/dL): Fasting lipid levels
Non-HDL-C
Time frame: Measured at 24 weeks
non-HDL-C (mg/dL): Fasting lipid levels
HDL-C
Time frame: Measured at 24 weeks
HDL-C (mg/dL): Fasting lipid levels
Total Cholesterol
Time frame: Measured at 24 weeks
Total cholesterol (mg/dL): Fasting lipid levels
Total Cholesterol : HDL-C Ratio
Time frame: Measured at 24 weeks
Total cholesterol : HDL-C ratio: Fasting lipid levels

2 secondary outcomes

Insulin Sensitivity
Time frame: Measured at 24 weeks
Body Composition
Time frame: Measured at 24 weeks

Results and safety

Results posted to the registry on 21 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Usual Care	41	26
Group 2: Diet / Exercise	43	24
Group 3: Diet / Exercise + Fenofibrate	45	29
Group 4: Diet / Exercise + Niacin	47	21
Group 5: Diet / Exercise + Niacin + Fenofibrate	45	28

Primary outcome: Triglycerides

Time frame: Measured at 24 weeks. Mean (Standard Error). Unit: mg/dL

Measure	Group 1 - Usual Care n = 30	Group 2 - Diet/Exercise Only n = 38	Group 3 - Diet/Exercise + Fenofibrate n = 41	Group 4 - Diet/Exercise + Niacin n = 40	Group 5 - Diet/Exercise + Fenofibrate + Niacin n = 42
Value	199 (24.9)	216.9 (28.6)	155.1 (18.5)	177.6 (24.2)	135.6 (16.9)

Population analysed: All those who underwent the 2-week (first follow-up) measurement and continued in the study.

Primary outcome: Non-HDL-C

Time frame: Measured at 24 weeks. Mean (Standard Error). Unit: mg/dl

Measure	Group 1 - Usual Care n = 30	Group 2 - Diet/Exercise Only n = 38	Group 3 - Diet/Exercise + Fenofibrate n = 41	Group 4 - Diet/Exercise + Niacin n = 40	Group 5 - Diet/Exercise + Fenofibrate + Niacin n = 42
Value	162.2 (7.8)	165.4 (8.1)	145.8 (7.4)	154 (8.3)	137.1 (7.7)

Population analysed: All those who underwent the 2-week (first follow-up) measurement and continued in the study.

Primary outcome: HDL-C

Time frame: Measured at 24 weeks. Mean (Standard Error). Unit: mg/dl

Measure	Group 1 - Usual Care n = 30	Group 2 - Diet/Exercise Only n = 38	Group 3 - Diet/Exercise + Fenofibrate n = 41	Group 4 - Diet/Exercise + Niacin n = 40	Group 5 - Diet/Exercise + Fenofibrate + Niacin n = 42
Value	37.1 (1.8)	38.7 (1.9)	40.7 (1.8)	41.8 (2.2)	44.8 (2.1)

Population analysed: All those who underwent the 2-week (first follow-up) measurement and continued in the study.

Primary outcome: Total Cholesterol

Time frame: Measured at 24 weeks. Mean (Standard Error). Unit: mg/dL

Measure	Group 1 - Usual Care n = 30	Group 2 - Diet/Exercise Only n = 38	Group 3 - Diet/Exercise + Fenofibrate n = 41	Group 4 - Diet/Exercise + Niacin n = 40	Group 5 - Diet/Exercise + Fenofibrate + Niacin n = 42
Value	195.6 (7.7)	200.1 (8.3)	184 (6.9)	190.8 (8.2)	178.4 (7)

Population analysed: All those who underwent the 2-week (first follow-up) measurement and continued in the study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout duration of study (5 years). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Usual Care	7 of 30 (23.3%)	17 of 30 (56.7%)	Not reported
Group 2: Diet / Exercise	10 of 38 (26.3%)	11 of 38 (28.9%)	Not reported
Group 3: Diet / Exercise + Fenofibrate	6 of 41 (14.6%)	12 of 41 (29.3%)	Not reported
Group 4: Diet / Exercise + Niacin	4 of 40 (10%)	33 of 40 (82.5%)	Not reported
Group 5: Diet / Exercise + Niacin + Fenofibrate	5 of 42 (11.9%)	25 of 42 (59.5%)	Not reported

Limitations and caveats (from the sponsor): High dropout rate, especially by loss to follow-up (with no explanation). Flushing was common among patients taking niacin, and this (with transportation and socio-economc problems) could have contributed to the high drop-out rate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16914390Samson SL, Pownall HJ, Scott LW, Ballantyne CM, Smith EO, Sekhar RV, Balasubramanyam A. Heart positive: design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/dyslipidemia. Contemp Clin Trials. 2006 Dec;27(6):518-30. doi: 10.1016/j.cct.2006.07.002. Epub 2006 Jul 21.
Results publication: PubMed 21565796Balasubramanyam A, Coraza I, Smith EO, Scott LW, Patel P, Iyer D, Taylor AA, Giordano TP, Sekhar RV, Clark P, Cuevas-Sanchez E, Kamble S, Ballantyne CM, Pownall HJ. Combination of niacin and fenofibrate with lifestyle changes improves dyslipidemia and hypoadiponectinemia in HIV patients on antiretroviral therapy: results of "heart positive," a randomized, controlled trial. J Clin Endocrinol Metab. 2011 Jul;96(7):2236-47. doi: 10.1210/jc.2010-3067. Epub 2011 May 11.
Derived from this study: PubMed 23640486Gillard BK, Raya JL, Ruiz-Esponda R, Iyer D, Coraza I, Balasubramanyam A, Pownall HJ. Impaired lipoprotein processing in HIV patients on antiretroviral therapy: aberrant high-density lipoprotein lipids, stability, and function. Arterioscler Thromb Vasc Biol. 2013 Jul;33(7):1714-21. doi: 10.1161/ATVBAHA.113.301538. Epub 2013 May 2.
Derived from this study: PubMed 23522788Vu CN, Ruiz-Esponda R, Yang E, Chang E, Gillard B, Pownall HJ, Hoogeveen RC, Coraza I, Balasubramanyam A. Altered relationship of plasma triglycerides to HDL cholesterol in patients with HIV/HAART-associated dyslipidemia: further evidence for a unique form of metabolic syndrome in HIV patients. Metabolism. 2013 Jul;62(7):1014-20. doi: 10.1016/j.metabol.2013.01.020. Epub 2013 Mar 19.
Derived from this study: PubMed 23299761Wooten JS, Nambi P, Gillard BK, Pownall HJ, Coraza I, Scott LW, Nambi V, Ballantyne CM, Balasubramanyam A. Intensive lifestyle modification reduces Lp-PLA2 in dyslipidemic HIV/HAART patients. Med Sci Sports Exerc. 2013 Jun;45(6):1043-50. doi: 10.1249/MSS.0b013e3182843961.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ashok Balasubramanyam, MD principal investigator

Baylor College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Diet, Exercise and Niacin in people with Cardiovascular Diseases and Heart Diseases, run by Baylor College of Medicine at 1 site 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 6 inclusion and 32 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 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2016). 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?

Triglycerides (time frame: Measured at 24 weeks). The study lists 5 primary outcomes in all. 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 NCT00246376, which also lists 5 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 21 Mar 2016.