search
Back to results

Preliminary Study of Safety and Efficacy of Policosanol

Primary Purpose

Dyslipidemia, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Policosanol
Placebo
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring HIV, lipids, dyslipidemia, policosanol, treatment experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Policosanol

Placebo

Arm Description

20 mg daily of policosanol

20 mg of microcrystalline cellulose daily

Outcomes

Primary Outcome Measures

LDL Cholesterol
Low density lipoprotein cholesterol

Secondary Outcome Measures

Triglycerides

Full Information

First Posted
April 7, 2006
Last Updated
July 19, 2013
Sponsor
Rush University Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00312923
Brief Title
Preliminary Study of Safety and Efficacy of Policosanol
Official Title
Preliminary Study of Safety and Efficacy of Policosanol
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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).
Detailed Description
As per Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, HIV Infections
Keywords
HIV, lipids, dyslipidemia, policosanol, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Policosanol
Arm Type
Experimental
Arm Description
20 mg daily of policosanol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 mg of microcrystalline cellulose daily
Intervention Type
Drug
Intervention Name(s)
Policosanol
Intervention Description
20 mg of policosanol in capsular form daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Two capsules of 10 mg of microcrystalline cellulose daily
Primary Outcome Measure Information:
Title
LDL Cholesterol
Description
Low density lipoprotein cholesterol
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Triglycerides
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara A Swanson, DNSc
Organizational Affiliation
Rush University College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Preliminary Study of Safety and Efficacy of Policosanol

We'll reach out to this number within 24 hrs