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Trial record 43 of 56 for:    " September 09, 2009":" October 09, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Study of Niacin on Endothelial Function in HIV-infected Subjects With Low High Density Lipoprotein Cholesterol Levels

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ClinicalTrials.gov Identifier: NCT00986986
Recruitment Status : Completed
First Posted : September 30, 2009
Results First Posted : December 18, 2012
Last Update Posted : December 18, 2012
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Dominic Chow, University of Hawaii

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Dyslipidemia
Endothelial Dysfunction
Intervention Drug: extended release niacin
Enrollment 20
Recruitment Details Recruitment was through the University of Hawaii, Hawaii Center for AIDS
Pre-assignment Details  
Arm/Group Title Active Drug (Extended Release Niacin) Observation
Hide Arm/Group Description Subjects in this arm will be given 12 weeks of extended release niacin Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
Period Title: Overall Study
Started 10 10
Completed 10 9
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Active Drug (Extended Release Niacin) Observation Total
Hide Arm/Group Description Subjects in this arm will be given 12 weeks of extended release niacin Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
49.96  (11.60) 47.72  (10.81) 48.84  (10.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
0
   0.0%
2
  20.0%
2
  10.0%
Male
10
 100.0%
8
  80.0%
18
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12
Hide Description Brachial arterial flow-mediated dilation (FMD), assessed by high-resolution ultrasonography, reflects endothelium-dependent vasodilator function. The primary outcome is the change in FMD from baseline to study week 12.
Time Frame Two time points (baseline and study week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
HIV infected patients with HDL-C < 40
Arm/Group Title Extended Release Niacin Observation
Hide Arm/Group Description:
HIV infected individuals receiving extended release niacin
Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: percentage change in FMD
6.36
(4.85 to 7.87)
2.73
(0.95 to 4.51)
2.Primary Outcome
Title Flow Mediated Vasodilation
Hide Description Flow mediated vasodilation is a marker of endothelial function
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Drug (Extended Release Niacin) Observation
Hide Arm/Group Description:
Subjects in this arm will be given 12 weeks of extended release niacin
Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: percentage change in FMD
4.51
(4.46 to 8.32)
3.25
(1.95 to 4.85)
3.Secondary Outcome
Title High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12
Hide Description HDL, often referred to "Good cholesterol levels", will be obtained in both arms. HDL is a marker of coronary heart disease.
Time Frame Two time points (baseline and study week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Drug (Extended Release Niacin) Observation
Hide Arm/Group Description:
Subjects in this arm will be given 12 weeks of extended release niacin
Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
42.0
(39.3 to 43.5)
27.0
(24.0 to 39.0)
4.Secondary Outcome
Title HDL
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Drug (Extended Release Niacin) Observation
Hide Arm/Group Description Subjects in this arm will be given 12 weeks of extended release niacin Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
All-Cause Mortality
Active Drug (Extended Release Niacin) Observation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Drug (Extended Release Niacin) Observation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Drug (Extended Release Niacin) Observation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
  • Small sample size
  • Un-blinded pilot study
  • Increase in HDL was less than predicted in a non-HIV infected population
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dominic Chow
Organization: University of Hawaii at Manoa
Phone: (808)737-2751
Responsible Party: Dominic Chow, University of Hawaii
ClinicalTrials.gov Identifier: NCT00986986     History of Changes
Other Study ID Numbers: ENDO
Department of Defense ( Other Grant/Funding Number: 06187003 )
First Submitted: September 29, 2009
First Posted: September 30, 2009
Results First Submitted: August 14, 2011
Results First Posted: December 18, 2012
Last Update Posted: December 18, 2012