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Preliminary Study of Safety and Efficacy of Policosanol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00312923
Recruitment Status : Completed
First Posted : April 11, 2006
Results First Posted : July 15, 2013
Last Update Posted : July 26, 2013
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Barbara Swanson, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE April 7, 2006
First Posted Date  ICMJE April 11, 2006
Results First Submitted Date  ICMJE May 23, 2013
Results First Posted Date  ICMJE July 15, 2013
Last Update Posted Date July 26, 2013
Study Start Date  ICMJE September 2005
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2013)
LDL Cholesterol [ Time Frame: 12 weeks ]
Low density lipoprotein cholesterol
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00312923 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2013)
Triglycerides [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preliminary Study of Safety and Efficacy of Policosanol
Official Title  ICMJE Preliminary Study of Safety and Efficacy of Policosanol
Brief Summary Lay Language Summary: High cholesterol levels are common in persons with HIV infection. However, conventional cholesterol-lowering medications may have harmful side effects when given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that policosanol will lower levels of LDL cholesterol ("bad" cholesterol) and raise levels of HDL cholesterol ("good" cholesterol).
Detailed Description As per Brief Summary
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dyslipidemia
  • HIV Infections
Intervention  ICMJE
  • Drug: Policosanol
    20 mg of policosanol in capsular form daily
  • Dietary Supplement: Placebo
    Two capsules of 10 mg of microcrystalline cellulose daily
Study Arms  ICMJE
  • Experimental: Policosanol
    20 mg daily of policosanol
    Intervention: Drug: Policosanol
  • Placebo Comparator: Placebo
    20 mg of microcrystalline cellulose daily
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2013)
54
Original Enrollment  ICMJE
 (submitted: April 7, 2006)
70
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

CD4 count > 250 Plasma HIV RNA < 50,000 Currently receiving HAART age 18-60 total cholesterol between 200-240 or triglycerides between 150-400 or LDL cholesterol > 160

Exclusion Criteria:

kidney or liver disease current use of lipid-lowering drugs pregnancy lactation

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00312923
Other Study ID Numbers  ICMJE R21AT003077-01( U.S. NIH Grant/Contract )
R21AT003077-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barbara Swanson, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Barbara A Swanson, DNSc Rush University College of Nursing
PRS Account Rush University Medical Center
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP