Preliminary Study of Safety and Efficacy of Policosanol
Recruitment status was Active, not recruiting
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-Related Dyslipidemia HIV Infections |
Dietary Supplement: Policosanol Dietary Supplement: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Preliminary Study of Safety and Efficacy of Policosanol |
- LDL Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Triglycerides, total cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
20 mg daily of policosanol
|
Dietary Supplement: Policosanol
20 mg of policosanol in capsular form daily
|
| Placebo Comparator: 2 |
Dietary Supplement: Placebo
Two capsules of microcrystalline cellulose daily
|
Detailed Description:
As per Brief Summary
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
-
Contacts and Locations| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Principal Investigator: | Barbara A Swanson, DNSc | Rush University College of Nursing |
More Information
No publications provided
| Responsible Party: | Barbara Swanson, PhD, RN, ACRN, Rush University College of Nursing |
| ClinicalTrials.gov Identifier: | NCT00312923 History of Changes |
| Other Study ID Numbers: | R21 AT003077-01 |
| Study First Received: | April 7, 2006 |
| Last Updated: | May 18, 2009 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
HIV lipids dyslipidemia policosanol treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Dyslipidemias Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Lipid Metabolism Disorders Metabolic Diseases Policosanol Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
ClinicalTrials.gov processed this record on March 03, 2013
