Preliminary Study of Safety and Efficacy of Policosanol

NCT00312923 | Completed Phase 2 Results DMC

• 1 other identifier: R21AT003077-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Dyslipidemia; HIV Infections

Keywords

HIV; lipids; dyslipidemia; policosanol; treatment experienced

Outcome Measures

Primary Outcomes (1)

• LDL Cholesterol

  Low density lipoprotein cholesterol

  12 weeks

Secondary Outcomes (1)

• Triglycerides

  12 weeks

Study Arms (2)

Policosanol

EXPERIMENTAL

20 mg daily of policosanol

Drug: Policosanol

Placebo

PLACEBO COMPARATOR

20 mg of microcrystalline cellulose daily

Dietary Supplement: Placebo

Interventions

Policosanol DRUG

20 mg of policosanol in capsular form daily

Policosanol

Placebo DIETARY_SUPPLEMENT

Two capsules of 10 mg of microcrystalline cellulose daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• kidney or liver disease current use of lipid-lowering drugs pregnancy lactation

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Dyslipidemias; HIV Infections

Interventions

policosanol

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

It is possible that other constituents underlie policosanol's lipid-lowering activity. One study found that triacontanol inhibited HMG-CoA reductase in rat liver cells. Triacontanol was not detected in either lot of policosanol used in this study.

Results Point of Contact

• Title: Barbara Swanson
• Organization: Rush University Medical Center

barbara_a_swanson@rush.edu

312-942-8977

Study Officials

• Barbara A Swanson, DNSc

  Rush University College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2006
• First Posted: April 11, 2006
• Study Start: September 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 26, 2013
• Results First Posted: July 15, 2013

Record last verified: 2013-07

Locations

US (1)