Preliminary Study of Safety and Efficacy of Policosanol

Rush

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia; HIV Infections

Treatments: Drug: Policosanol; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00312923

R21AT003077-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

As per Brief Summary

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

Policosanol

Experimental group

Description:

20 mg daily of policosanol

Treatment:

Drug: Policosanol

Placebo

Placebo Comparator group

Description:

20 mg of microcrystalline cellulose daily

Treatment:

Dietary Supplement: Placebo