Preliminary Study of Safety and Efficacy of Policosanol

Rush University Medical Center54 enrolled

Overview

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).

As per Brief Summary

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dyslipidemia HIV Infections

Interventions

PolicosanolDRUG

20 mg of policosanol in capsular form daily

PlaceboDIETARY_SUPPLEMENT

Two capsules of 10 mg of microcrystalline cellulose daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

LDL Cholesterol

Low density lipoprotein cholesterol

Time frame: 12 weeks

Secondary Outcomes

Triglycerides

Time frame: 12 weeks

Data from ClinicalTrials.gov

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