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Preliminary Study of Safety and Efficacy of Policosanol

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

Condition Intervention Phase
HIV Infections
Drug: Policosanol
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Preliminary Study of Safety and Efficacy of Policosanol

Resource links provided by NLM:

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • LDL Cholesterol [ Time Frame: 12 weeks ]
    Low density lipoprotein cholesterol

Secondary Outcome Measures:
  • Triglycerides [ Time Frame: 12 weeks ]

Enrollment: 54
Study Start Date: September 2005
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Policosanol
20 mg daily of policosanol
Drug: Policosanol
20 mg of policosanol in capsular form daily
Placebo Comparator: Placebo
20 mg of microcrystalline cellulose daily
Dietary Supplement: Placebo
Two capsules of 10 mg of microcrystalline cellulose daily

Detailed Description:
As per Brief Summary

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00312923

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Barbara A Swanson, DNSc Rush University College of Nursing
  More Information

Responsible Party: Barbara Swanson, Assistant Professor, Rush University Medical Center Identifier: NCT00312923     History of Changes
Other Study ID Numbers: R21AT003077-01 ( US NIH Grant/Contract Award Number )
Study First Received: April 7, 2006
Results First Received: May 23, 2013
Last Updated: July 19, 2013

Keywords provided by Rush University Medical Center:
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Platelet Aggregation Inhibitors processed this record on May 22, 2017