Dyslipidemia, HIV Infections
Conditions
Keywords
HIV, lipids, dyslipidemia, policosanol, treatment experienced
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).
Detailed description
As per Brief Summary
Interventions
DRUGPolicosanol
20 mg of policosanol in capsular form daily
DIETARY_SUPPLEMENTPlacebo
Two capsules of 10 mg of microcrystalline cellulose daily
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL Cholesterol | 12 weeks | Low density lipoprotein cholesterol |
Secondary
| Measure | Time frame |
|---|---|
| Triglycerides | 12 weeks |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group 20 mg daily of policosanol
Policosanol : 20 mg of policosanol in capsular form daily | 28 |
| Control Group Placebo : Two capsules of 10 mg of microcrystalline cellulose daily | 26 |
| Total | 54 |
Baseline characteristics
| Characteristic | Total | Treatment Group | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 28 Participants | 26 Participants |
| Age Continuous | 44.67 years STANDARD_DEVIATION 6.04 | 44.6 years STANDARD_DEVIATION 0.54 | 46.8 years STANDARD_DEVIATION 6.56 |
| Region of Enrollment United States | 54 participants | 28 participants | 26 participants |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 39 Participants | 21 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
LDL Cholesterol
Low density lipoprotein cholesterol
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | LDL Cholesterol | 116.34 mg/dl | Standard Deviation 37.75 |
| Control Group | LDL Cholesterol | 118.84 mg/dl | Standard Deviation 38.38 |
Secondary
Triglycerides
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Triglycerides | 173.73 mg/dl | Standard Deviation 200.39 |
| Control Group | Triglycerides | 186.69 mg/dl | Standard Deviation 125.6 |