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Preliminary Study of Safety and Efficacy of Policosanol

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Barbara Swanson, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00312923
First received: April 7, 2006
Last updated: July 19, 2013
Last verified: July 2013

April 7, 2006
July 19, 2013
September 2005
July 2009   (final data collection date for primary outcome measure)
LDL Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Low density lipoprotein cholesterol
Not Provided
Complete list of historical versions of study NCT00312923 on ClinicalTrials.gov Archive Site
Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00312923
R21AT003077-01, R21AT003077-01
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