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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dominic Chow, University of Hawaii
ClinicalTrials.gov Identifier:
NCT00986986
First received: September 29, 2009
Last updated: November 19, 2012
Last verified: July 2012
Results First Received: August 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Dyslipidemia
Endothelial Dysfunction
Intervention: Drug: extended release niacin

  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
Recruitment was through the University of Hawaii, Hawaii Center for AIDS

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Active Drug (Extended Release Niacin) Subjects in this arm will be given 12 weeks of extended release niacin
Observation Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin

Participant Flow:   Overall Study
    Active Drug (Extended Release Niacin)     Observation  
STARTED     10     10  
COMPLETED     10     9  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  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
Active Drug (Extended Release Niacin) Subjects in this arm will be given 12 weeks of extended release niacin
Observation Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
Total Total of all reporting groups

Baseline Measures
    Active Drug (Extended Release Niacin)     Observation     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  49.96  ± 11.60     47.72  ± 10.81     48.84  ± 10.94  
Gender  
[units: participants]
     
Female     0     2     2  
Male     10     8     18  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures
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1.  Primary:   Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12   [ Time Frame: Two time points (baseline and study week 12) ]

2.  Primary:   Flow Mediated Vasodilation   [ Time Frame: 12 weeks ]

3.  Secondary:   High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12   [ Time Frame: Two time points (baseline and study week 12) ]

4.  Secondary:   HDL   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
  • Small sample size
  • Un-blinded pilot study
  • Increase in HDL was less than predicted in a non-HIV infected population
 


Results Point of Contact:  
Name/Title: Dominic Chow
Organization: University of Hawaii at Manoa
phone: (808)737-2751
e-mail: dominicc@hawaii.edu


Publications of Results:

Responsible Party: Dominic Chow, University of Hawaii
ClinicalTrials.gov Identifier: NCT00986986     History of Changes
Other Study ID Numbers: ENDO, Department of Defense
Study First Received: September 29, 2009
Results First Received: August 14, 2011
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board