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

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ClinicalTrials.gov Identifier: NCT00246376
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Legacy Community Health Center
Information provided by (Responsible Party):
Ashok Balasubramanyam, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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
Enrollment 221
Recruitment Details 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 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.
Arm/Group Title Group 1: Usual Care Group 2: Diet / Exercise Group 3: Diet / Exercise + Fenofibrate Group 4: Diet / Exercise + Niacin Group 5: Diet / Exercise + Niacin + Fenofibrate
Hide Arm/Group Description Subjects receive lifestyle advice and placebos for Niaspan and Tricor Diet, exercise, and two placebos Diet, exercise, Fenofibrate, and Niaspan placebo Diet, exercise, Fenofibrate placebo, and Niaspan Diet, exercise, Fenofibrate and Niaspan
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title 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
Hide Arm/Group Description Subjects receive lifestyle advice and placebos for Niaspan and Tricor Diet, exercise, and two placebos Diet, exercise, Fenofibrate, and Niaspan placebo Diet, exercise, Fenofibrate placebo, and Niaspan Diet, exercise, Fenofibrate and Niaspan Total of all reporting groups
Overall Number of Baseline Participants 41 43 45 47 45 221
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 45 participants 47 participants 45 participants 221 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
  97.6%
43
 100.0%
45
 100.0%
47
 100.0%
45
 100.0%
220
  99.5%
>=65 years
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 45 participants 47 participants 45 participants 221 participants
Female
4
   9.8%
4
   9.3%
9
  20.0%
5
  10.6%
7
  15.6%
29
  13.1%
Male
37
  90.2%
39
  90.7%
36
  80.0%
42
  89.4%
38
  84.4%
192
  86.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 43 participants 45 participants 47 participants 45 participants 221 participants
41 43 45 47 45 221
1.Primary Outcome
Title Triglycerides
Hide Description Triglycerides (mg/dL): Fasting lipid levels
Time Frame Measured at 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All those who underwent the 2-week (first follow-up) measurement and continued in the study.
Arm/Group Title Group 1 - Usual Care Group 2 - Diet/Exercise Only Group 3 - Diet/Exercise + Fenofibrate Group 4 - Diet/Exercise + Niacin Group 5 - Diet/Exercise + Fenofibrate + Niacin
Hide Arm/Group Description:
These subjects did not participate in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Overall Number of Participants Analyzed 30 38 41 40 42
Mean (Standard Error)
Unit of Measure: mg/dL
199  (24.9) 216.9  (28.6) 155.1  (18.5) 177.6  (24.2) 135.6  (16.9)
2.Primary Outcome
Title Non-HDL-C
Hide Description non-HDL-C (mg/dL): Fasting lipid levels
Time Frame Measured at 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All those who underwent the 2-week (first follow-up) measurement and continued in the study.
Arm/Group Title Group 1 - Usual Care Group 2 - Diet/Exercise Only Group 3 - Diet/Exercise + Fenofibrate Group 4 - Diet/Exercise + Niacin Group 5 - Diet/Exercise + Fenofibrate + Niacin
Hide Arm/Group Description:
These subjects did not participate in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Overall Number of Participants Analyzed 30 38 41 40 42
Mean (Standard Error)
Unit of Measure: mg/dl
162.2  (7.8) 165.4  (8.1) 145.8  (7.4) 154  (8.3) 137.1  (7.7)
3.Primary Outcome
Title HDL-C
Hide Description HDL-C (mg/dL): Fasting lipid levels
Time Frame Measured at 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All those who underwent the 2-week (first follow-up) measurement and continued in the study.
Arm/Group Title Group 1 - Usual Care Group 2 - Diet/Exercise Only Group 3 - Diet/Exercise + Fenofibrate Group 4 - Diet/Exercise + Niacin Group 5 - Diet/Exercise + Fenofibrate + Niacin
Hide Arm/Group Description:
These subjects did not participate in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Overall Number of Participants Analyzed 30 38 41 40 42
Mean (Standard Error)
Unit of Measure: mg/dl
37.1  (1.8) 38.7  (1.9) 40.7  (1.8) 41.8  (2.2) 44.8  (2.1)
4.Primary Outcome
Title Total Cholesterol
Hide Description Total cholesterol (mg/dL): Fasting lipid levels
Time Frame Measured at 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All those who underwent the 2-week (first follow-up) measurement and continued in the study.
Arm/Group Title Group 1 - Usual Care Group 2 - Diet/Exercise Only Group 3 - Diet/Exercise + Fenofibrate Group 4 - Diet/Exercise + Niacin Group 5 - Diet/Exercise + Fenofibrate + Niacin
Hide Arm/Group Description:
These subjects did not participate in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Overall Number of Participants Analyzed 30 38 41 40 42
Mean (Standard Error)
Unit of Measure: mg/dL
195.6  (7.7) 200.1  (8.3) 184  (6.9) 190.8  (8.2) 178.4  (7)
5.Primary Outcome
Title Total Cholesterol : HDL-C Ratio
Hide Description Total cholesterol : HDL-C ratio: Fasting lipid levels
Time Frame Measured at 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All those who underwent the 2-week (first follow-up) measurement and continued in the study.
Arm/Group Title Group 1 - Usual Care Group 2 - Diet/Exercise Only Group 3 - Diet/Exercise + Fenofibrate Group 4 - Diet/Exercise + Niacin Group 5 - Diet/Exercise + Fenofibrate + Niacin
Hide Arm/Group Description:
These subjects did not participate in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took placebos.
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Overall Number of Participants Analyzed 30 38 41 40 42
Mean (Standard Error)
Unit of Measure: ratio
5.2  (0.3) 5.1  (0.3) 4.5  (0.2) 4.6  (0.3) 4  (0.2)
6.Secondary Outcome
Title Insulin Sensitivity
Hide Description Adiponectin (micrograms/ml)
Time Frame Measured at 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed 24 weeks.
Arm/Group Title Group 1 - Usual Care Group 2 - Diet/Exercise Only Group 3 - Diet/Exercise + Fenofibrate Group 4 - Diet/Exercise + Niacin Group 5 - Diet/Exercise + Fenofibrate + Niacin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 26 24 29 21 28
Mean (Standard Error)
Unit of Measure: micrograms/ml
Fasting insulin 8.7  (2) 6.7  (1.6) 9.5  (1.6) 11.9  (3) 10.3  (2.5)
HOMA-IR 1.92  (0.47) 1.38  (0.36) 2.02  (0.47) 2.76  (0.75) 2.38  (0.62)
Insulin sensitvity index 3.54  (0.73) 4.95  (1.1) 3.81  (0.76) 2.88  (0.67) 2.38  (0.62)
Adiponectin 7.12  (1.09) 6.04  (0.98) 5.24  (0.76) 11.01  (1.87) 10.34  (1.67)
7.Secondary Outcome
Title Body Composition
Hide Description
  1. Body cell mass (kg)
  2. Fat mass (kg)
Time Frame Measured at 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number corresponds to the number of subjects who completed the study (see Participant flow)
Arm/Group Title Group 1 - Usual Care Group 2 - Diet/Exercise Group 3 - Diet/Exercise + Fenofibrate Group 4 - Diet/Exercise + Niacin Group 5 - Diet/Exercise + Fenofibrate + Niacin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 26 24 29 21 28
Mean (Standard Error)
Unit of Measure: kg
Body cell mass 59.6  (2.3) 67.3  (2) 66.6  (1.8) 67.1  (2.1) 68.2  (2)
Fat mass 36.8  (1.9) 37.5  (1.6) 35.8  (1.5) 37.7  (1.8) 36.2  (1.7)
Time Frame Throughout duration of study (5 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Usual Care Group 2: Diet / Exercise Group 3: Diet / Exercise + Fenofibrate Group 4: Diet / Exercise + Niacin Group 5: Diet / Exercise + Niacin + Fenofibrate
Hide Arm/Group Description Subjects receive lifestyle advice and placebos for Niaspan and Tricor Diet, exercise, and two placebos Diet, exercise, Fenofibrate, and Niaspan placebo Diet, exercise, Fenofibrate placebo, and Niaspan Diet, exercise, Fenofibrate and Niaspan
All-Cause Mortality
Group 1: Usual Care Group 2: Diet / Exercise Group 3: Diet / Exercise + Fenofibrate Group 4: Diet / Exercise + Niacin Group 5: Diet / Exercise + Niacin + Fenofibrate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Usual Care Group 2: Diet / Exercise Group 3: Diet / Exercise + Fenofibrate Group 4: Diet / Exercise + Niacin Group 5: Diet / Exercise + Niacin + Fenofibrate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/30 (23.33%)      10/38 (26.32%)      6/41 (14.63%)      4/40 (10.00%)      5/42 (11.90%)    
Cardiac disorders           
Chest pain / angina *  1/30 (3.33%)  1 1/38 (2.63%)  1 1/41 (2.44%)  1 1/40 (2.50%)  1 0/42 (0.00%)  0
Hepatobiliary disorders           
Transaminases elevated >3 times upper normal limit *  1/30 (3.33%)  1 1/38 (2.63%)  1 0/41 (0.00%)  0 1/40 (2.50%)  1 2/42 (4.76%)  2
Elevated Bilirubin * [1]  3/30 (10.00%)  3 5/38 (13.16%)  5 4/41 (9.76%)  4 0/40 (0.00%)  0 2/42 (4.76%)  2
Metabolism and nutrition disorders           
Triglycerides > 1000mg/dl * [2]  1/30 (3.33%)  1 3/38 (7.89%)  3 0/41 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Renal and urinary disorders           
Serum creatining > 1.5 mg/dL *  1/30 (3.33%)  1 0/38 (0.00%)  0 1/41 (2.44%)  1 1/40 (2.50%)  1 1/42 (2.38%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Elevated Bilirubin
[2]
hypertriglyceridemia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Group 1: Usual Care Group 2: Diet / Exercise Group 3: Diet / Exercise + Fenofibrate Group 4: Diet / Exercise + Niacin Group 5: Diet / Exercise + Niacin + Fenofibrate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/30 (56.67%)      11/38 (28.95%)      12/41 (29.27%)      33/40 (82.50%)      25/42 (59.52%)    
Cardiac disorders           
Acute myocardial infarction *  0/30 (0.00%)  0 1/38 (2.63%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Ear and labyrinth disorders           
Dizziness *  1/30 (3.33%)  1 1/38 (2.63%)  1 0/41 (0.00%)  0 1/40 (2.50%)  1 1/42 (2.38%)  1
Gastrointestinal disorders           
Diarrhea *  3/30 (10.00%)  3 1/38 (2.63%)  1 2/41 (4.88%)  2 2/40 (5.00%)  2 0/42 (0.00%)  0
Nausea/Vomiting *  2/30 (6.67%)  2 1/38 (2.63%)  1 4/41 (9.76%)  4 0/40 (0.00%)  0 3/42 (7.14%)  3
Abdominal pain *  1/30 (3.33%)  1 2/38 (5.26%)  2 0/41 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
General disorders           
Fatigue *  2/30 (6.67%)  2 0/38 (0.00%)  0 1/41 (2.44%)  1 1/40 (2.50%)  1 2/42 (4.76%)  2
Loss of appetite *  1/30 (3.33%)  1 1/38 (2.63%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 1/42 (2.38%)  1
Hepatobiliary disorders           
Acute cholecystitis *  0/30 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain *  0/30 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 2/40 (5.00%)  2 1/42 (2.38%)  1
Headache *  5/30 (16.67%)  5 0/38 (0.00%)  0 0/41 (0.00%)  0 2/40 (5.00%)  2 0/42 (0.00%)  0
Body ache *  0/30 (0.00%)  0 1/38 (2.63%)  1 0/41 (0.00%)  0 1/40 (2.50%)  1 2/42 (4.76%)  2
Leg cramps *  0/30 (0.00%)  0 1/38 (2.63%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 1/42 (2.38%)  1
Psychiatric disorders           
Suicide attempt *  0/30 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury *  0/30 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Kidney stone *  0/30 (0.00%)  0 0/38 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Polyuria *  0/30 (0.00%)  0 0/38 (0.00%)  0 1/41 (2.44%)  1 1/40 (2.50%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders           
Rash/Itching *  1/30 (3.33%)  1 0/38 (0.00%)  0 0/41 (0.00%)  0 3/40 (7.50%)  3 2/42 (4.76%)  2
Flushing *  1/30 (3.33%)  1 2/38 (5.26%)  2 3/41 (7.32%)  3 16/40 (40.00%)  16 12/42 (28.57%)  12
*
Indicates events were collected by non-systematic assessment
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.
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
Responsible Party: Ashok Balasubramanyam, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00246376     History of Changes
Other Study ID Numbers: H-14105
R01HL073696 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 2005
First Posted: October 31, 2005
Results First Submitted: October 20, 2015
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016