Preliminary Study of Safety and Efficacy of Policosanol

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-09-30

Brief Summary

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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).

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Detailed Description

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As per Brief Summary

Conditions

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Dyslipidemia HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Policosanol

20 mg daily of policosanol

Group Type EXPERIMENTAL

Policosanol

Intervention Type DRUG

20 mg of policosanol in capsular form daily

Placebo

20 mg of microcrystalline cellulose daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Two capsules of 10 mg of microcrystalline cellulose daily

Interventions

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Policosanol

20 mg of policosanol in capsular form daily

Intervention Type DRUG

Placebo

Two capsules of 10 mg of microcrystalline cellulose daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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