CClinicalTrials.gg
Sign In
CompletedNCT00246376HeartPositiveUpdated Mar 21, 2016Results posted

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

An interventional study of Diet and Exercise in Cardiovascular Diseases, Heart Diseases and HIV Infections, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-21.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
221
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
  • HIV Infections
  • Hyperlipidemia
  • Hypertriglyceridemia
  • Insulin Resistance
  • Atherosclerosis
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 221 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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:

    1. Omega-3 fatty acids
    2. L-Carnitine
    3. Soluble fiber supplements
    4. Guggul
    5. Garlic supplements
    6. Niacin greater than 25mg/d
    7. 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
221 participants (actual)

Study arms

  • Placebo comparator
    1

    Subjects receive lifestyle advice and placebos for Niaspan and Tricor

    Other: Placebos

  • Experimental
    2

    Diet, exercise, and two placebos

    Behavioral: Diet · Behavioral: Exercise · Other: Placebos

  • Experimental
    3

    Diet, exercise, Niaspan, and placebo

    Behavioral: Diet · Behavioral: Exercise · Drug: Niacin · Other: Placebos

  • Experimental
    4

    Diet, exercise, placebo, and Tricor

    Behavioral: Diet · Behavioral: Exercise · Drug: Fenofibrate · Other: Placebos

  • Experimental
    5

    Diet, exercise, Niaspan, and Tricor

    Behavioral: Diet · Behavioral: Exercise · Drug: Niacin · Drug: Fenofibrate

Interventions

  • BehavioralDiet

    ATP-III diet

  • BehavioralExercise

    Supervised exercise in study gym

  • DrugNiacin

    Niaspan, titrated up to 2 grams per day

  • DrugFenofibrate

    Tricor, 120 mg per day

  • OtherPlacebos

    Placebos for Niaspan and Tricor

06

What researchers measure

Primary outcomes

  1. Triglycerides

    Triglycerides (mg/dL): Fasting lipid levels

    Time frame: Measured at 24 weeks

  2. Non-HDL-C

    non-HDL-C (mg/dL): Fasting lipid levels

    Time frame: Measured at 24 weeks

  3. HDL-C

    HDL-C (mg/dL): Fasting lipid levels

    Time frame: Measured at 24 weeks

  4. Total Cholesterol

    Total cholesterol (mg/dL): Fasting lipid levels

    Time frame: Measured at 24 weeks

  5. Total Cholesterol : HDL-C Ratio

    Total cholesterol : HDL-C ratio: Fasting lipid levels

    Time frame: Measured at 24 weeks

Secondary outcomes

  1. Insulin Sensitivity

    Adiponectin (micrograms/ml)

    Time frame: Measured at 24 weeks

  2. Body Composition

    1. Body cell mass (kg) 2. Fat mass (kg)

    Time frame: Measured at 24 weeks

07

Results

Posted Mar 21, 2016
Limitations and caveats
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.

Participant flow

Subjects were recruited mainly from the Legacy Community Health Center and Thomas Street Clinic of the Harris County Hospital District and from Houston Area Community Services and private clinics. Recruitment period: January 2004 to September 2009.

Participant flow — Overall Study
MilestoneGroup 1: Usual CareGroup 2: Diet / ExerciseGroup 3: Diet / Exercise + FenofibrateGroup 4: Diet / Exercise + NiacinGroup 5: Diet / Exercise + Niacin + Fenofibrate
Started4143454745
After dietary run-in at two weeks3038414042
Completed2624292128
Not completed1519162617
Withdrew: Dropped/withdrew during dietary run-in115473
Withdrew: Adverse event23131
Withdrew: Lost to follow-up211111613

Outcome measures

PrimaryTriglycerides

Triglycerides (mg/dL): Fasting lipid levels

Time frame:
Measured at 24 weeks
Reported as:
Mean · mg/dL
Triglycerides
mg/dLGroup 1 - Usual CareGroup 2 - Diet/Exercise OnlyGroup 3 - Diet/Exercise + FenofibrateGroup 4 - Diet/Exercise + NiacinGroup 5 - Diet/Exercise + Fenofibrate + Niacin
Triglycerides199 ± 24.9216.9 ± 28.6155.1 ± 18.5177.6 ± 24.2135.6 ± 16.9
SecondaryInsulin Sensitivity

Adiponectin (micrograms/ml)

Time frame:
Measured at 24 weeks
Reported as:
Mean · micrograms/ml
Insulin Sensitivity
micrograms/mlGroup 1 - Usual CareGroup 2 - Diet/Exercise OnlyGroup 3 - Diet/Exercise + FenofibrateGroup 4 - Diet/Exercise + NiacinGroup 5 - Diet/Exercise + Fenofibrate + Niacin
Fasting insulin8.7 ± 26.7 ± 1.69.5 ± 1.611.9 ± 310.3 ± 2.5
HOMA-IR1.92 ± 0.471.38 ± 0.362.02 ± 0.472.76 ± 0.752.38 ± 0.62
Insulin sensitvity index3.54 ± 0.734.95 ± 1.13.81 ± 0.762.88 ± 0.672.38 ± 0.62
Adiponectin7.12 ± 1.096.04 ± 0.985.24 ± 0.7611.01 ± 1.8710.34 ± 1.67
SecondaryBody Composition

1. Body cell mass (kg) 2. Fat mass (kg)

Time frame:
Measured at 24 weeks
Reported as:
Mean · kg
Body Composition
kgGroup 1 - Usual CareGroup 2 - Diet/ExerciseGroup 3 - Diet/Exercise + FenofibrateGroup 4 - Diet/Exercise + NiacinGroup 5 - Diet/Exercise + Fenofibrate + Niacin
Body cell mass59.6 ± 2.367.3 ± 266.6 ± 1.867.1 ± 2.168.2 ± 2
Fat mass36.8 ± 1.937.5 ± 1.635.8 ± 1.537.7 ± 1.836.2 ± 1.7
PrimaryNon-HDL-C

non-HDL-C (mg/dL): Fasting lipid levels

Time frame:
Measured at 24 weeks
Reported as:
Mean · mg/dl
Non-HDL-C
mg/dlGroup 1 - Usual CareGroup 2 - Diet/Exercise OnlyGroup 3 - Diet/Exercise + FenofibrateGroup 4 - Diet/Exercise + NiacinGroup 5 - Diet/Exercise + Fenofibrate + Niacin
Non-HDL-C162.2 ± 7.8165.4 ± 8.1145.8 ± 7.4154 ± 8.3137.1 ± 7.7
PrimaryHDL-C

HDL-C (mg/dL): Fasting lipid levels

Time frame:
Measured at 24 weeks
Reported as:
Mean · mg/dl
HDL-C
mg/dlGroup 1 - Usual CareGroup 2 - Diet/Exercise OnlyGroup 3 - Diet/Exercise + FenofibrateGroup 4 - Diet/Exercise + NiacinGroup 5 - Diet/Exercise + Fenofibrate + Niacin
HDL-C37.1 ± 1.838.7 ± 1.940.7 ± 1.841.8 ± 2.244.8 ± 2.1
PrimaryTotal Cholesterol

Total cholesterol (mg/dL): Fasting lipid levels

Time frame:
Measured at 24 weeks
Reported as:
Mean · mg/dL
Total Cholesterol
mg/dLGroup 1 - Usual CareGroup 2 - Diet/Exercise OnlyGroup 3 - Diet/Exercise + FenofibrateGroup 4 - Diet/Exercise + NiacinGroup 5 - Diet/Exercise + Fenofibrate + Niacin
Total Cholesterol195.6 ± 7.7200.1 ± 8.3184 ± 6.9190.8 ± 8.2178.4 ± 7
PrimaryTotal Cholesterol : HDL-C Ratio

Total cholesterol : HDL-C ratio: Fasting lipid levels

Time frame:
Measured at 24 weeks
Reported as:
Mean · ratio
Total Cholesterol : HDL-C Ratio
ratioGroup 1 - Usual CareGroup 2 - Diet/Exercise OnlyGroup 3 - Diet/Exercise + FenofibrateGroup 4 - Diet/Exercise + NiacinGroup 5 - Diet/Exercise + Fenofibrate + Niacin
Total Cholesterol : HDL-C Ratio5.2 ± 0.35.1 ± 0.34.5 ± 0.24.6 ± 0.34 ± 0.2

Adverse events

Collected over Throughout duration of study (5 years). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Usual Care—7/30 (23.3%)17/30 (56.7%)
Group 2: Diet / Exercise—10/38 (26.3%)11/38 (28.9%)
Group 3: Diet / Exercise + Fenofibrate—6/41 (14.6%)12/41 (29.3%)
Group 4: Diet / Exercise + Niacin—4/40 (10%)33/40 (82.5%)
Group 5: Diet / Exercise + Niacin + Fenofibrate—5/42 (11.9%)25/42 (59.5%)
Most frequent serious events
Most frequent serious events
EventGroup 1: Usual CareGroup 2: Diet / ExerciseGroup 3: Diet / Exercise + FenofibrateGroup 4: Diet / Exercise + NiacinGroup 5: Diet / Exercise + Niacin + Fenofibrate
Elevated BilirubinHepatobiliary disorders3/305/384/410/402/42
Triglycerides > 1000mg/dlMetabolism and nutrition disorders1/303/380/411/400/42
Transaminases elevated >3 times upper normal limitHepatobiliary disorders1/301/380/411/402/42
Chest pain / anginaCardiac disorders1/301/381/411/400/42
Serum creatining > 1.5 mg/dLRenal and urinary disorders1/300/381/411/401/42
Most frequent other events
Showing 10 of 18
Most frequent other events
EventGroup 1: Usual CareGroup 2: Diet / ExerciseGroup 3: Diet / Exercise + FenofibrateGroup 4: Diet / Exercise + NiacinGroup 5: Diet / Exercise + Niacin + Fenofibrate
FlushingSkin and subcutaneous tissue disorders1/302/383/4116/4012/42
HeadacheMusculoskeletal and connective tissue disorders5/300/380/412/400/42
DiarrheaGastrointestinal disorders3/301/382/412/400/42
Nausea/VomitingGastrointestinal disorders2/301/384/410/403/42
Rash/ItchingSkin and subcutaneous tissue disorders1/300/380/413/402/42
FatigueGeneral disorders2/300/381/411/402/42
Abdominal painGastrointestinal disorders1/302/380/411/400/42
Back painMusculoskeletal and connective tissue disorders0/300/380/412/401/42
Body acheMusculoskeletal and connective tissue disorders0/301/380/411/402/42
DizzinessEar and labyrinth disorders1/301/380/411/401/42

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group 1: Usual CareGroup 2: Diet / ExerciseGroup 3: Diet / Exercise + FenofibrateGroup 4: Diet / Exercise + NiacinGroup 5: Diet / Exercise + Niacin + FenofibrateTotal
<=18 years000000
Between 18 and 65 years4043454745220
>=65 years100001
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: Usual CareGroup 2: Diet / ExerciseGroup 3: Diet / Exercise + FenofibrateGroup 4: Diet / Exercise + NiacinGroup 5: Diet / Exercise + Niacin + FenofibrateTotal
Female4495729
Male3739364238192
Region of Enrollment
Region of Enrollment(participants)Group 1: Usual CareGroup 2: Diet / ExerciseGroup 3: Diet / Exercise + FenofibrateGroup 4: Diet / Exercise + NiacinGroup 5: Diet / Exercise + Niacin + FenofibrateTotal
United States4143454745221
08

Study locations

1 site
  • Baylor College of Medicine
    Houston, Texas 77098, United States
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00246376
Lead sponsor
Baylor College of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Legacy Community Health Center
Responsible party
Ashok Balasubramanyam (Principal Investigator, Baylor College of Medicine) — Principal investigator
First posted
Oct 30, 2005
Start date
Jan 2004
Primary completion
Sep 2009
Completion
Feb 2012
Results posted
Mar 21, 2016
Last update
Mar 21, 2016

Study contacts

Ashok Balasubramanyam, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cardiovascular Diseases→

Other studies from this sponsor

Baylor College of Medicine

Start the discussion