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Preliminary Study of Safety and Efficacy of Policosanol

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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:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Dyslipidemia HIV Infections Drug: Policosanol Dietary Supplement: Placebo Phase 2

Detailed Description:
As per Brief Summary

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Preliminary Study of Safety and Efficacy of Policosanol
Study Start Date : September 2005
Primary Completion Date : July 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Secondary Outcome Measures :
  1. Triglycerides [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312923


Locations
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)
Investigators
Principal Investigator: Barbara A Swanson, DNSc Rush University College of Nursing
More Information

Responsible Party: Barbara Swanson, Assistant Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00312923     History of Changes
Other Study ID Numbers: R21AT003077-01 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2006    Key Record Dates
Results First Posted: July 15, 2013
Last Update Posted: July 26, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
HIV Infections
Dyslipidemias
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
Policosanol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Platelet Aggregation Inhibitors