HIV Infections, Hyperlipidemia
Conditions
Keywords
Treatment Experienced
Brief summary
Treatment of HIV with combination antiretroviral regimens frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with these regimens, particularly protease inhibitors (PIs), has been associated with significant increases in cholesterol and triglycerides in HIV-infected adults and children. The purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.
Detailed description
Antiretroviral regimens, particularly those containing PIs, often cause hyperlipidemia, which is an increase in the amount of fat (such as cholesterol and triglycerides) in the blood. These increases can lead to heart disease and pancreatitis. Although the mechanism by which PIs cause hyperlipidemia is not clearly understood, there are medications to combat this side effect. The primary purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, based on low-density lipoprotein cholesterol (LDL-C) levels, in HIV-infected children receiving stable antiretroviral therapy. Participants were assigned to one of two groups based on age (10 to 14 years or 15 to 23 years) and were treated for a maximum of 48 weeks. The first six participants enrolled in the study were in the 15 to 23 year old age group. Once safety data through week 8 on these 6 participants was analyzed, the remaining participants were enrolled. All participants received atorvastatin in combination with a stable antiretroviral regimen. Each participant was followed independently according to a dose escalation algorithm for atorvastatin. Participants began dosing at 10 mg daily. If efficacy criteria were not met, dosing increased to 20 mg daily at week 8. Since dose escalations were done within subject, safety and efficacy rates were presented for the dose-escalation strategy overall and not for individual doses. Atorvastatin was provided by the study, but antiretrovirals were not. Study visits occurred at study entry and weeks 4, 8, 12, 24, 36, and 48. Safety labs were collected at all study visits. Blood collection for lipid measurements occurred at weeks 4, 12, 24 and 48.
Interventions
DRUGAtorvastatin
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 23 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of HIV-1 infection * CD4 % of at least 15 at screening * HIV-1 viral load of less than 10,000 copies/ml at screening * On a stable antiretroviral therapy regimen for at least 6 months * Tanner stage of 2 or higher * At least two LDL-C measurements of 130 mg/dL or higher over the 6 months prior to screening and after documented attempts at modifying diet and other risk factors. More information on this criterion can be found in the protocol. * Able to fast overnight for 8 hours * Negative pregnancy test at screening * Agree to use two appropriate forms of contraception (female participants). More information on this criterion can be found in the protocol.
Exclusion criteria
* Certain abnormal laboratory values * Any laboratory or unresolved clinical toxicity of Grade 3 or higher * Unlikely to remain on current antiretroviral therapy for at least six months after study entry * Use of statin, fibrate, or niacin within 3 months prior to study entry * Evidence of chronic ongoing myositis or history of myopathy or neuromuscular disorder * Symptomatic peripheral neuropathy within 6 months prior to study entry * Pharmacologic treatment for depression or other mental disorder excluding Attention Deficit Disorder within 30 days prior to study entry * Presence of an active CDC Stage C opportunistic infection or serious bacterial infection requiring therapy within 2 weeks prior to screening. * Chemotherapy for malignancy within 3 months prior to study entry * Hepatitis B Surface Antigen positive * Hepatitis C viremia * Insulin-dependent diabetes mellitus * Required treatment with an agent contraindicated with either atorvastatin or PIs. More information on this criterion can be found in the protocol. * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group | Study entry to weeks 12, 24, and 48 | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat) | Study entry and weeks 4, 12, 24, and 48 | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available) | Study entry and weeks 4, 12, 24, and 48 | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol) | Study entry and weeks 4, 12, 24, and 48 | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug | Study entry and weeks 4, 12, 24, and 48 | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Study entry and weeks 4, 12, 24, and 48 | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Study entry and weeks 4, 12, 24, and 48 | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. |
| Percent Change in LDL Cholesterol (LDL-C) From Study Entry | Study entry and weeks 4, 12, 24, and 48 | — |
| Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group | Study entry to weeks 12, 24, and 48 | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. |
| Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) | Study entry to weeks 12, 24, and 48 | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. |
| Percentage of Participants Experiencing at Least One Adverse Event (AE) | Study entry to weeks 12, 24, and 48 | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Triglycerides (TG) From Study Entry | Study entry and weeks 4, 12, 24, and 48 | — |
| Percent Change in HDL-cholesterol (HDL-C) From Study Entry | Study entry and weeks 4, 12, 24, and 48 | — |
| Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry | Study entry and weeks 12, 24, and 48 | — |
| Percent Change in Apolipoprotein B (Apo B) From Study Entry | Study entry and weeks 12, 24, and 48 | — |
| Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry | Study entry and weeks 12, 24, and 48 | — |
| Percent Change in Interleukin 6 (IL-6) From Study Entry | Study entry and weeks 12, 24, and 48 | — |
| Percentage of Participants With Undetectable Plasma HIV-1 RNA | Study entry and weeks 12, 24, and 48 | Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used. |
| Percent Change in Fasting Total Cholesterol (TC) From Study Entry | Study entry and weeks 4, 12, 24, and 48 | — |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between August 31, 2009 (date first participant enrolled) and December 16, 2013 (date last participant enrolled).
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not willing to adhere to requirements | 1 |
Baseline characteristics
| Characteristic | Atorvastatin |
|---|---|
| Age, Continuous | 17 years STANDARD_DEVIATION 4 |
| Age, Customized 10 - <15 years old | 7 participants |
| Age, Customized 15 - <19 years old | 12 participants |
| Age, Customized 19 - <24 years old | 9 participants |
| Antiretroviral (ARV) Regimen at entry, Categorical At least one NNRTI and no PI | 4 participants |
| Antiretroviral (ARV) Regimen at entry, Categorical At least one PI and at least one NNRTI | 5 participants |
| Antiretroviral (ARV) Regimen at entry, Categorical At least one PI and no NNRTI | 17 participants |
| Antiretroviral (ARV) Regimen at entry, Categorical Other ARV regimen | 2 participants |
| CD4 Percent at screening, Categorical 15% to <25% | 2 participants |
| CD4 Percent at screening, Categorical >=25% | 26 participants |
| HIV-1 RNA, Categorical <Lower limit of quantification of assay | 20 participants |
| HIV-1 RNA, Categorical >=Lower limit of quantification of assay | 8 participants |
| Race/Ethnicity, Customized Asian, Pacific Islander | 1 participants |
| Race/Ethnicity, Customized Black Non-Hispanic | 18 participants |
| Race/Ethnicity, Customized Hispanic (Regardless of Race) | 5 participants |
| Race/Ethnicity, Customized White Non-Hispanic | 4 participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 28 |
| serious Total, serious adverse events | 3 / 28 |
Outcome results
Primary
Percentage of Participants Experiencing at Least One Adverse Event (AE)
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Time frame: Study entry to weeks 12, 24, and 48
Population: All participants who initiated Atorvastatin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Experiencing at Least One Adverse Event (AE) | Week 12 | 21.4 percentage of participants |
| Atorvastatin | Percentage of Participants Experiencing at Least One Adverse Event (AE) | Week 24 | 21.4 percentage of participants |
| Atorvastatin | Percentage of Participants Experiencing at Least One Adverse Event (AE) | Week 48 | 28.6 percentage of participants |
Primary
Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Time frame: Study entry to weeks 12, 24, and 48
Population: All participants who initiated Atorvastatin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group | Week 12 | 14.3 percentage of participants |
| Atorvastatin | Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group | Week 24 | 14.3 percentage of participants |
| Atorvastatin | Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group | Week 48 | 28.6 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group | Week 12 | 23.8 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group | Week 24 | 23.8 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group | Week 48 | 28.6 percentage of participants |
Primary
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Time frame: Study entry to weeks 12, 24, and 48
Population: All participants who initiated Atorvastatin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) | Week 12 | 3.6 percentage of participants |
| Atorvastatin | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) | Week 24 | 3.6 percentage of participants |
| Atorvastatin | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) | Week 48 | 7.1 percentage of participants |
Primary
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Time frame: Study entry to weeks 12, 24, and 48
Population: All participants who initiated Atorvastatin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group | Week 12 | 14.3 percentage of participants |
| Atorvastatin | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group | Week 24 | 14.3 percentage of participants |
| Atorvastatin | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group | Week 48 | 28.6 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group | Week 12 | 0 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group | Week 24 | 0 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group | Week 48 | 0 percentage of participants |
Primary
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who initiated Atorvastatin and did not experience a primary safety event attributable to Atorvastatin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug | Week 4 | 57.7 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug | Week 12 | 50.0 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug | Week 24 | 57.7 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug | Week 48 | 53.9 percentage of participants |
Primary
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Week 4 | 71.4 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Week 12 | 28.6 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Week 24 | 71.4 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Week 48 | 71.4 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Week 48 | 47.6 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Week 4 | 57.1 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Week 24 | 52.4 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Week 12 | 52.4 percentage of participants |
Primary
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Week 4 | 66.7 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Week 12 | 55.6 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Week 24 | 44.4 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Week 48 | 55.6 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Week 48 | 52.6 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Week 4 | 57.9 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Week 24 | 63.2 percentage of participants |
| 15 to 23 Years Old | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Week 12 | 42.1 percentage of participants |
Primary
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who initiated study treatment and have LDL-C data available at study entry and the specified week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available) | Week 4 (N=27) | 63.0 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available) | Week 12 (N=27) | 48.2 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available) | Week 24 (N=26) | 61.5 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available) | Week 48 (N=26) | 57.7 percentage of participants |
Primary
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat) | Week 4 | 60.7 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat) | Week 12 | 46.4 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat) | Week 24 | 57.1 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat) | Week 48 | 53.6 percentage of participants |
Primary
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who completed the study per protocol (initiated study drug, had LDL-C data available at all required study visits, attended study visits within the protocol-specified window, were dose-escalated according to protocol, and reported adherence to study drug at all study visits).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol) | Week 4 | 69.2 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol) | Week 12 | 69.2 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol) | Week 24 | 84.6 percentage of participants |
| Atorvastatin | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol) | Week 48 | 53.9 percentage of participants |
Primary
Percent Change in LDL Cholesterol (LDL-C) From Study Entry
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who initiated Atorvastatin and had LDL-C data available at study entry and the specified week.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Atorvastatin | Percent Change in LDL Cholesterol (LDL-C) From Study Entry | Percent change in LDL-C at Week 4 (N=27) | -30.3 percentage of LDL-C at study entry |
| Atorvastatin | Percent Change in LDL Cholesterol (LDL-C) From Study Entry | Percent change in LDL-C at Week 12 (N=27) | -26.5 percentage of LDL-C at study entry |
| Atorvastatin | Percent Change in LDL Cholesterol (LDL-C) From Study Entry | Percent change in LDL-C at Week 24 (N=26) | -28.0 percentage of LDL-C at study entry |
| Atorvastatin | Percent Change in LDL Cholesterol (LDL-C) From Study Entry | Percent change in LDL-C at Week 48 (N=26) | -26.4 percentage of LDL-C at study entry |
Secondary
Percentage of Participants With Undetectable Plasma HIV-1 RNA
Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used.
Time frame: Study entry and weeks 12, 24, and 48
Population: All study participants who initiated Atorvastatin and had HIV-1 RNA data available at the specified week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants With Undetectable Plasma HIV-1 RNA | Week 0 (N=28) | 71.0 percentage of participants |
| Atorvastatin | Percentage of Participants With Undetectable Plasma HIV-1 RNA | Week 12 (N=26) | 69.0 percentage of participants |
| Atorvastatin | Percentage of Participants With Undetectable Plasma HIV-1 RNA | Week 24 (N=26) | 62.0 percentage of participants |
| Atorvastatin | Percentage of Participants With Undetectable Plasma HIV-1 RNA | Week 48 (N=26) | 69.0 percentage of participants |
Secondary
Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry
Time frame: Study entry and weeks 12, 24, and 48
Population: All participants who initiated Atorvastatin and had Apo A-1 data available at study entry and the specified week.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Atorvastatin | Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry | Percent change in Apo A-1 at Week 24 (N=23) | 2.4 percentage of Apo A-1 at study entry |
| Atorvastatin | Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry | Percent change in Apo A-1 at Week 48 (N=24) | 0.3 percentage of Apo A-1 at study entry |
| Atorvastatin | Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry | Percent change in Apo A-1 at Week 12 (N=24) | 0.8 percentage of Apo A-1 at study entry |
Secondary
Percent Change in Apolipoprotein B (Apo B) From Study Entry
Time frame: Study entry and weeks 12, 24, and 48
Population: All participants who initiated Atorvastatin and had Apo B data available at study entry and the specified week.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Atorvastatin | Percent Change in Apolipoprotein B (Apo B) From Study Entry | Percent change in Apo B at Week 12 (N=24) | -27.2 percentage of Apo B at study entry |
| Atorvastatin | Percent Change in Apolipoprotein B (Apo B) From Study Entry | Percent change in Apo B at Week 24 (N=23) | -25.1 percentage of Apo B at study entry |
| Atorvastatin | Percent Change in Apolipoprotein B (Apo B) From Study Entry | Percent change in Apo B at Week 48 (N=24) | -23.8 percentage of Apo B at study entry |
Secondary
Percent Change in Fasting Total Cholesterol (TC) From Study Entry
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who initiated Atorvastatin and had total cholesterol data available at study entry and the specified week.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Atorvastatin | Percent Change in Fasting Total Cholesterol (TC) From Study Entry | Percent change in TC at Week 4 (N=27) | -23.8 percentage of TC at study entry |
| Atorvastatin | Percent Change in Fasting Total Cholesterol (TC) From Study Entry | Percent change in TC at Week 12 (N=27) | -21.1 percentage of TC at study entry |
| Atorvastatin | Percent Change in Fasting Total Cholesterol (TC) From Study Entry | Percent change in TC at Week 24 (N=26) | -22.5 percentage of TC at study entry |
| Atorvastatin | Percent Change in Fasting Total Cholesterol (TC) From Study Entry | Percent change in TC at Week 48 (N=26) | -21.5 percentage of TC at study entry |
Secondary
Percent Change in HDL-cholesterol (HDL-C) From Study Entry
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who initiated Atorvastatin and had HDL-C data available at study entry and the specified week.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Atorvastatin | Percent Change in HDL-cholesterol (HDL-C) From Study Entry | Percent change in HDL-C at Week 4 (N=27) | 1.8 percentage of HDL-C at study entry |
| Atorvastatin | Percent Change in HDL-cholesterol (HDL-C) From Study Entry | Percent change in HDL-C at Week 12 (N=27) | 2.3 percentage of HDL-C at study entry |
| Atorvastatin | Percent Change in HDL-cholesterol (HDL-C) From Study Entry | Percent change in HDL-C at Week 24 (N=26) | 3.0 percentage of HDL-C at study entry |
| Atorvastatin | Percent Change in HDL-cholesterol (HDL-C) From Study Entry | Percent change in HDL-C at Week 48 (N=26) | 4.2 percentage of HDL-C at study entry |
Secondary
Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry
Time frame: Study entry and weeks 12, 24, and 48
Population: All participants who initiated Atorvastatin and had hs-CRP data available at study entry and the specified week.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atorvastatin | Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry | Percent change in hs-CRP at Week 12 (N=25) | 0 percentage of hs-CRP at study entry |
| Atorvastatin | Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry | Percent change in hs-CRP at Week 24 (N=23) | -20 percentage of hs-CRP at study entry |
| Atorvastatin | Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry | Percent change in hs-CRP at Week 48 (N=24) | 0 percentage of hs-CRP at study entry |
Secondary
Percent Change in Interleukin 6 (IL-6) From Study Entry
Time frame: Study entry and weeks 12, 24, and 48
Population: All participants who initiated Atorvastatin and had IL-6 data available at study entry and the specified week.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atorvastatin | Percent Change in Interleukin 6 (IL-6) From Study Entry | Percent change in IL-6 at Week 12 (N=24) | -1 percentage of IL-6 at study entry |
| Atorvastatin | Percent Change in Interleukin 6 (IL-6) From Study Entry | Percent change in IL-6 at Week 24 (N=23) | -19 percentage of IL-6 at study entry |
| Atorvastatin | Percent Change in Interleukin 6 (IL-6) From Study Entry | Percent change in IL-6 at Week 48 (N=24) | -11.5 percentage of IL-6 at study entry |
Secondary
Percent Change in Triglycerides (TG) From Study Entry
Time frame: Study entry and weeks 4, 12, 24, and 48
Population: All participants who initiated Atorvastatin and had triglycerides data available at study entry and the specified week.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Atorvastatin | Percent Change in Triglycerides (TG) From Study Entry | Percent change in TG at Week 4 (N=27) | -9.5 percentage of TG at study entry |
| Atorvastatin | Percent Change in Triglycerides (TG) From Study Entry | Percent change in TG at Week 12 (N=27) | -12.6 percentage of TG at study entry |
| Atorvastatin | Percent Change in Triglycerides (TG) From Study Entry | Percent change in TG at Week 24 (N=26) | -11.3 percentage of TG at study entry |
| Atorvastatin | Percent Change in Triglycerides (TG) From Study Entry | Percent change in TG at Week 48 (N=26) | -12.6 percentage of TG at study entry |