A Phase 2 interventional study of Policosanol and Placebo in Dyslipidemia and HIV Infections, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-26.
Sponsored by Rush University Medical Center · Phase 2, Interventional, and Treatment
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
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 54 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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20 mg daily of policosanol
Drug: Policosanol
20 mg of microcrystalline cellulose daily
Dietary Supplement: Placebo
20 mg of policosanol in capsular form daily
Two capsules of 10 mg of microcrystalline cellulose daily
LDL Cholesterol
Low density lipoprotein cholesterol
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
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).
| Milestone | Treatment Group | Control Group |
|---|---|---|
| Started | 28 | 26 |
| Completed | 19 | 20 |
| Not completed | 9 | 6 |
Low density lipoprotein cholesterol
| mg/dl | Treatment Group | Control Group |
|---|---|---|
| LDL Cholesterol | 116.34 ± 37.75 | 118.84 ± 38.38 |
| mg/dl | Treatment Group | Control Group |
|---|---|---|
| Triglycerides | 173.73 ± 200.39 | 186.69 ± 125.60 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | — | — | — |
| Control Group | — | — | — |
54 eligible participants were randomized to the study arms. 39 participants completed the study. An intent-to-treat analysis was performed.
| Age, Categorical(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 26 | 54 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 44.6 ± .54 | 46.8 ± 6.56 | 44.67 ± 6.04 |
| Sex: Female, Male(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 21 | 18 | 39 |
| Region of Enrollment(participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| United States | 28 | 26 | 54 |
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Rush University Medical Center