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NCT00312923 Clinical Trial

Preliminary Study of Safety and Efficacy of Policosanol

HIV Infections Clinical Trial

Official title:
Preliminary Study of Safety and Efficacy of Policosanol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00312923
Other study ID # R21AT003077-01
Secondary ID R21AT003077-01
Status Completed
Phase Phase 2
First received April 7, 2006
Last updated July 19, 2013
Start date September 2005
Est. completion date September 2009

Study information
Verified date July 2013
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Description:

As per Brief Summary

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date September 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Policosanol
20 mg of policosanol in capsular form daily
Dietary Supplement:
• Placebo
Two capsules of 10 mg of microcrystalline cellulose daily

Locations
Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Rush University Medical Center National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary LDL Cholesterol Low density lipoprotein cholesterol 12 weeks No
Secondary Triglycerides 12 weeks No
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