Preliminary Study of Safety and Efficacy of Policosanol

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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
Dyslipidemia
HIV Infections
Drug: Policosanol
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    Low density lipoprotein cholesterol


Secondary Outcome Measures:
  • Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Barbara A Swanson, DNSc Rush University College of Nursing
  More Information

No publications provided

Responsible Party: Barbara Swanson, Assistant Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00312923     History of Changes
Other Study ID Numbers: R21 AT003077-01, R21AT003077-01
Study First Received: April 7, 2006
Results First Received: May 23, 2013
Last Updated: July 19, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Rush University Medical Center:
HIV
lipids
dyslipidemia
policosanol
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Dyslipidemias
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Policosanol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on August 19, 2014