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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT003077-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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).
As per Brief Summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Policosanol | Experimental | 20 mg daily of policosanol |
|
| Placebo | Placebo Comparator | 20 mg of microcrystalline cellulose daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Policosanol | Drug | 20 mg of policosanol in capsular form daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| LDL Cholesterol | Low density lipoprotein cholesterol | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides | 12 weeks |
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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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| Name | Affiliation | Role |
|---|---|---|
| Barbara A Swanson, DNSc | Rush University College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
A total of 176 participants were screened for eligibility and 54 were randomized and entered into the intent-to-treat analyses. Most of the ineligible participants did not meet the study's lipid criteria
The study was conducted between April, 2006 and July, 2009 at three inner-city outpatient HIV/AIDS clinics located in a Chicago neighborhood that has been designated as medically underserved by the Health Resources Service Administration (HRSA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | 20 mg daily of policosanol Policosanol : 20 mg of policosanol in capsular form daily |
| FG001 | Control Group | Placebo : Two capsules of 10 mg of microcrystalline cellulose daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
54 eligible participants were randomized to the study arms. 39 participants completed the study. An intent-to-treat analysis was performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | 20 mg daily of policosanol Policosanol : 20 mg of policosanol in capsular form daily |
| BG001 | Control Group | Placebo : Two capsules of 10 mg of microcrystalline cellulose daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LDL Cholesterol | Low density lipoprotein cholesterol | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | 20 mg daily of policosanol Policosanol : 20 mg of policosanol in capsular form daily |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Swanson | Rush University Medical Center | 312-942-8977 | barbara_a_swanson@rush.edu |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000086982 | Blood-Borne Infections |
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| ID | Term |
|---|---|
| C080710 | policosanol |
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| Placebo |
| Dietary Supplement |
Two capsules of 10 mg of microcrystalline cellulose daily |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Triglycerides | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Group | Placebo : Two capsules of 10 mg of microcrystalline cellulose daily | 0 | 0 | 0 | 0 |
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| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |