Preliminary Study of Safety and Efficacy of Policosanol

Phase 2

Completed

• Conditions: Dyslipidemia; HIV Infections
• Interventions: Drug: Policosanol; Dietary Supplement: Placebo

• Registration Number: NCT00312923
• Lead Sponsor: Rush University Medical Center

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

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-04-07
• Study First Submitted QC: 2006-04-07
• Study First Posted: 2006-04-11
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Results First Submitted: 2013-05-23
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-12
• Results First Posted: 2013-07-15
• Last Update Submitted: 2013-07-19
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Policosanol	Policosanol	20 mg daily of policosanol
Placebo	Placebo	20 mg of microcrystalline cellulose daily

Primary Outcome Measures

Name	Time	Method
LDL Cholesterol	12 weeks	Low density lipoprotein cholesterol

Secondary Outcome Measures

Name	Time	Method
Triglycerides	12 weeks

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States