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

NCT00246376 | Completed Results DMC

• 2 other identifiers: H-14105R01HL073696
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Heart Diseases; HIV Infections; Hyperlipidemia; Hypertriglyceridemia; Insulin Resistance; Atherosclerosis

Outcome Measures

Primary Outcomes (5)

• Triglycerides

  Triglycerides (mg/dL): Fasting lipid levels

  Measured at 24 weeks

• Non-HDL-C

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

  Measured at 24 weeks

• HDL-C

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

  Measured at 24 weeks

• Total Cholesterol

  Total cholesterol (mg/dL): Fasting lipid levels

  Measured at 24 weeks

• Total Cholesterol : HDL-C Ratio

  Total cholesterol : HDL-C ratio: Fasting lipid levels

  Measured at 24 weeks

Secondary Outcomes (2)

• Insulin Sensitivity

  Measured at 24 weeks

• Body Composition

  Measured at 24 weeks

Study Arms (5)

1

PLACEBO COMPARATOR

Subjects receive lifestyle advice and placebos for Niaspan and Tricor

Other: Placebos

2

EXPERIMENTAL

Diet, exercise, and two placebos

Behavioral: Diet; Behavioral: Exercise; Other: Placebos

3

EXPERIMENTAL

Diet, exercise, Niaspan, and placebo

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

4

EXPERIMENTAL

Diet, exercise, placebo, and Tricor

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

5

EXPERIMENTAL

Diet, exercise, Niaspan, and Tricor

Behavioral: Diet; Behavioral: Exercise; Drug: Niacin; Drug: Fenofibrate

Interventions

Diet BEHAVIORAL

ATP-III diet

2; 3; 4; 5

Exercise BEHAVIORAL

Supervised exercise in study gym

2; 3; 4; 5

Niacin DRUG

Niaspan, titrated up to 2 grams per day

3; 5

Fenofibrate DRUG

Tricor, 120 mg per day

4; 5

Placebos OTHER

Placebos for Niaspan and Tricor

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Omega-3 fatty acids
• L-Carnitine
• Soluble fiber supplements
• Guggul
• Garlic supplements
• Niacin greater than 25mg/d

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Legacy Community Health Center: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77098, United States

Location

Related Publications (5)

• 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.

  PMID: 16914390 BACKGROUND

• 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.

  PMID: 21565796 RESULT

• 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.

  PMID: 23640486 DERIVED

• 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.

  PMID: 23522788 DERIVED

• 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.

  PMID: 23299761 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; HIV Infections; Hyperlipidemias; Hypertriglyceridemia; Insulin Resistance; Atherosclerosis

Interventions

Diet; Exercise; Niacin; Fenofibrate

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

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.

Results Point of Contact

• Title: Ashok Balasubramanyam, MD, Prinicipal Investigator
• Organization: Baylor College of Medicine

ashokb@bcm.edu

713-798-8654

Study Officials

• Ashok Balasubramanyam, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: January 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2012
• Last Updated: March 21, 2016
• Results First Posted: March 21, 2016

Record last verified: 2016-02

Locations

US (1)