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OpenTrials
Completed

NCT Number: NCT00312923

Preliminary Study of Safety and Efficacy of Policosanol

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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Key information

Conditions

Dyslipidemia Blood-Borne Infections Communicable Diseases Dyslipidemias Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

As per Brief Summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Policosanol

Drug

20 mg of policosanol in capsular form daily

Placebo

Dietary Supplement

Two capsules of 10 mg of microcrystalline cellulose daily

Primary outcomes

  1. LDL Cholesterol

    Time frame: 12 weeks

    Low density lipoprotein cholesterol

Secondary outcomes

  1. Triglycerides

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Apr 11, 2006
Registry last updated
Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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