Phase 2
N=54
Preliminary Study of Safety and Efficacy of Policosanol
Dyslipidemia · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00312923 ↗Enrolled (actual)
54
Serious AEs
—
Results posted
Jul 2013
Primary outcome: Primary: LDL Cholesterol — 116.34; 118.84 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Policosanol (Drug); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LDL Cholesterol |
116.34; 118.84 | — |
| SECONDARY Triglycerides |
173.73; 186.69 | — |
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).
Eligibility Criteria
Inclusion Criteria
CD4 count > 250 Plasma HIV RNA 160
Exclusion Criteria
kidney or liver disease current use of lipid-lowering drugs pregnancy lactation
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Data sourced from ClinicalTrials.gov (NCT00312923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.