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

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Legacy Community Health Center
Information provided by (Responsible Party):
Ashok Balasubramanyam, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00246376
First received: October 27, 2005
Last updated: February 25, 2016
Last verified: February 2016
Results First Received: October 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Cardiovascular Diseases
Heart Diseases
HIV Infections
Hyperlipidemia
Hypertriglyceridemia
Insulin Resistance
Atherosclerosis
Interventions: Behavioral: Diet
Behavioral: Exercise
Drug: Niacin
Drug: Fenofibrate
Other: Placebos

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If potential subjects were taking nutritional supplements or lipid-lowering drugs, these were discontinued for washout for 6 weeks - baseline fasting lipid levels were then measured to determine eligibility prior to randomization.

Reporting Groups
  Description
Group 1: Usual Care Subjects receive lifestyle advice and placebos for Niaspan and Tricor
Group 2: Diet / Exercise Diet, exercise, and two placebos
Group 3: Diet / Exercise + Fenofibrate Diet, exercise, Fenofibrate, and Niaspan placebo
Group 4: Diet / Exercise + Niacin Diet, exercise, Fenofibrate placebo, and Niaspan
Group 5: Diet / Exercise + Niacin + Fenofibrate Diet, exercise, Fenofibrate and Niaspan

Participant Flow:   Overall Study
    Group 1: Usual Care     Group 2: Diet / Exercise     Group 3: Diet / Exercise + Fenofibrate     Group 4: Diet / Exercise + Niacin     Group 5: Diet / Exercise + Niacin + Fenofibrate  
STARTED     41     43     45     47     45  
After Dietary run-in at Two Weeks     30     38     41     40     42  
COMPLETED     26     24     29     21     28  
NOT COMPLETED     15     19     16     26     17  
Dropped/withdrew during dietary run-in                 11                 5                 4                 7                 3  
Adverse Event                 2                 3                 1                 3                 1  
Lost to Follow-up                 2                 11                 11                 16                 13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1: Usual Care Subjects receive lifestyle advice and placebos for Niaspan and Tricor
Group 2: Diet / Exercise Diet, exercise, and two placebos
Group 3: Diet / Exercise + Fenofibrate Diet, exercise, Fenofibrate, and Niaspan placebo
Group 4: Diet / Exercise + Niacin Diet, exercise, Fenofibrate placebo, and Niaspan
Group 5: Diet / Exercise + Niacin + Fenofibrate Diet, exercise, Fenofibrate and Niaspan
Total Total of all reporting groups

Baseline Measures
    Group 1: Usual Care     Group 2: Diet / Exercise     Group 3: Diet / Exercise + Fenofibrate     Group 4: Diet / Exercise + Niacin     Group 5: Diet / Exercise + Niacin + Fenofibrate     Total  
Number of Participants  
[units: participants]
  41     43     45     47     45     221  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     40     43     45     47     45     220  
>=65 years     1     0     0     0     0     1  
Gender  
[units: participants]
           
Female     4     4     9     5     7     29  
Male     37     39     36     42     38     192  
Region of Enrollment  
[units: participants]
           
United States     41     43     45     47     45     221  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Triglycerides   [ Time Frame: Measured at 24 weeks ]

2.  Primary:   Non-HDL-C   [ Time Frame: Measured at 24 weeks ]

3.  Primary:   HDL-C   [ Time Frame: Measured at 24 weeks ]

4.  Primary:   Total Cholesterol   [ Time Frame: Measured at 24 weeks ]

5.  Primary:   Total Cholesterol : HDL-C Ratio   [ Time Frame: Measured at 24 weeks ]

6.  Secondary:   Insulin Sensitivity   [ Time Frame: Measured at 24 weeks ]

7.  Secondary:   Body Composition   [ Time Frame: Measured at 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ashok Balasubramanyam, MD, Prinicipal Investigator
Organization: Baylor College of Medicine
phone: 713-798-8654
e-mail: ashokb@bcm.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ashok Balasubramanyam, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00246376     History of Changes
Other Study ID Numbers: H-14105
R01HL073696 ( US NIH Grant/Contract Award Number )
Study First Received: October 27, 2005
Results First Received: October 20, 2015
Last Updated: February 25, 2016
Health Authority: United States: Federal Government