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Preliminary Study of Safety and Efficacy of Policosanol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00312923
First Posted: April 11, 2006
Last Update Posted: July 26, 2013
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.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Barbara Swanson, Rush University Medical Center
April 7, 2006
April 11, 2006
May 23, 2013
July 15, 2013
July 26, 2013
September 2005
July 2009   (Final data collection date for primary outcome measure)
LDL Cholesterol [ Time Frame: 12 weeks ]
Low density lipoprotein cholesterol
Not Provided
Complete list of historical versions of study NCT00312923 on ClinicalTrials.gov Archive Site
Triglycerides [ Time Frame: 12 weeks ]
Not Provided
Not Provided
Not Provided
 
Preliminary Study of Safety and Efficacy of Policosanol
Preliminary Study of Safety and Efficacy of Policosanol
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).
As per Brief Summary
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Dyslipidemia
  • HIV Infections
  • Drug: Policosanol
    20 mg of policosanol in capsular form daily
  • Dietary Supplement: Placebo
    Two capsules of 10 mg of microcrystalline cellulose daily
  • Experimental: Policosanol
    20 mg daily of policosanol
    Intervention: Drug: Policosanol
  • Placebo Comparator: Placebo
    20 mg of microcrystalline cellulose daily
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
September 2009
July 2009   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00312923
R21AT003077-01( U.S. NIH Grant/Contract )
R21AT003077-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Barbara Swanson, Rush University Medical Center
Rush University Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Barbara A Swanson, DNSc Rush University College of Nursing
Rush University Medical Center
July 2013

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