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TerminatedNCT00663234Updated Apr 6, 2016Results posted

IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia

A Phase 1/2 interventional study of Atorvastatin in HIV Infections and Hyperlipidemia, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. Terminated at 11 sites in United States. Open to participants aged 10 Years to 23 Years. Per ClinicalTrials.gov, last updated 2016-04-06.

Sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Phase 1/2, Interventional, and Treatment

Why this study was terminated
The study was prematurely discontinued due to administrative reasons.
Phase
Phase 1/2
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
10 Years to 23 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections
  • Hyperlipidemia

Keywords

  • Treatment Experienced
03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 28 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group is the lead sponsor of 26 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 23 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Age 10 to 14

    Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen

    Drug: Atorvastatin

  • Experimental
    Age 15 to 23

    Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen

    Drug: Atorvastatin

Interventions

  • DrugAtorvastatin

    10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.

    Also known as: Lipitor

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Percent Change in LDL Cholesterol (LDL-C) From Study Entry

    Time frame: Study entry and weeks 4, 12, 24, and 48

  10. 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

  11. 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

Secondary outcomes

  1. Percent Change in Fasting Total Cholesterol (TC) From Study Entry

    Time frame: Study entry and weeks 4, 12, 24, and 48

  2. Percent Change in Triglycerides (TG) From Study Entry

    Time frame: Study entry and weeks 4, 12, 24, and 48

  3. Percent Change in HDL-cholesterol (HDL-C) From Study Entry

    Time frame: Study entry and weeks 4, 12, 24, and 48

  4. Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry

    Time frame: Study entry and weeks 12, 24, and 48

  5. Percent Change in Apolipoprotein B (Apo B) From Study Entry

    Time frame: Study entry and weeks 12, 24, and 48

  6. Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry

    Time frame: Study entry and weeks 12, 24, and 48

  7. Percent Change in Interleukin 6 (IL-6) From Study Entry

    Time frame: Study entry and weeks 12, 24, and 48

  8. 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

07

Results

Posted Apr 6, 2016
Limitations and caveats
Target enrollment was 40 participants (20 in each age cohort). However, the study was prematurely discontinued due to administrative reasons, having enrolled only 28 participants (21 participants aged 10 to 14 and 7 participants aged 15 to 23).

Participant flow

Recruitment occurred between August 31, 2009 (date first participant enrolled) and December 16, 2013 (date last participant enrolled).

Participant flow — Overall Study
MilestoneAtorvastatin
Started28
Dose increased to 20 mg at week 810
Completed27
Not completed1
Withdrew: Not willing to adhere to requirements1

Outcome measures

PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)
percentage of participantsAtorvastatin
Week 123.6 (0.2 to 15.9)
Week 243.6 (0.2 to 15.9)
Week 487.1 (1.3 to 20.8)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing at Least One Adverse Event (AE)
percentage of participantsAtorvastatin
Week 1221.4 (9.8 to 38.0)
Week 2421.4 (9.8 to 38.0)
Week 4828.6 (15.1 to 45.7)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)
percentage of participantsAtorvastatin
Week 460.7 (43.5 to 76.2)
Week 1246.4 (30.1 to 63.4)
Week 2457.1 (40.0 to 73.1)
Week 4853.6 (36.6 to 69.9)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)
percentage of participantsAtorvastatin
Week 4 (N=27)63.0 (45.3 to 78.3)
Week 12 (N=27)48.2 (31.3 to 65.3)
Week 24 (N=26)61.5 (43.6 to 77.4)
Week 48 (N=26)57.7 (39.8 to 74.2)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)
percentage of participantsAtorvastatin
Week 469.2 (42.7 to 88.7)
Week 1269.2 (42.7 to 88.7)
Week 2484.6 (59.0 to 97.2)
Week 4853.9 (28.7 to 77.6)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug
percentage of participantsAtorvastatin
Week 457.7 (39.8 to 74.2)
Week 1250.0 (32.7 to 67.3)
Week 2457.7 (39.8 to 74.2)
Week 4853.9 (36.2 to 70.8)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group
percentage of participants10 to 14 Years Old15 to 23 Years Old
Week 471.4 (34.1 to 94.7)57.1 (37.2 to 75.5)
Week 1228.6 (5.3 to 65.9)52.4 (32.8 to 71.4)
Week 2471.4 (34.1 to 94.7)52.4 (32.8 to 71.4)
Week 4871.4 (34.1 to 94.7)47.6 (28.6 to 67.2)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment
percentage of participantsNNRTI-exposedNNRTI-unexposed
Week 466.7 (34.5 to 90.2)57.9 (36.8 to 77.0)
Week 1255.6 (25.1 to 83.1)42.1 (23.0 to 63.2)
Week 2444.4 (16.9 to 74.9)63.2 (41.8 to 81.3)
Week 4855.6 (25.1 to 83.1)52.6 (32.0 to 72.6)
PrimaryPercent Change in LDL Cholesterol (LDL-C) From Study Entry
Time frame:
Study entry and weeks 4, 12, 24, and 48
Reported as:
Mean · percentage of LDL-C at study entry
Percent Change in LDL Cholesterol (LDL-C) From Study Entry
percentage of LDL-C at study entryAtorvastatin
Percent change in LDL-C at Week 4 (N=27)-30.3 (-34.6 to -26.1)
Percent change in LDL-C at Week 12 (N=27)-26.5 (-32.4 to -20.5)
Percent change in LDL-C at Week 24 (N=26)-28.0 (-32.7 to -23.4)
Percent change in LDL-C at Week 48 (N=26)-26.4 (-33.1 to -19.7)
SecondaryPercent Change in Fasting Total Cholesterol (TC) From Study Entry
Time frame:
Study entry and weeks 4, 12, 24, and 48
Reported as:
Mean · percentage of TC at study entry
Percent Change in Fasting Total Cholesterol (TC) From Study Entry
percentage of TC at study entryAtorvastatin
Percent change in TC at Week 4 (N=27)-23.8 (-26.8 to -20.8)
Percent change in TC at Week 12 (N=27)-21.1 (-25.1 to -17.1)
Percent change in TC at Week 24 (N=26)-22.5 (-26.0 to -19.0)
Percent change in TC at Week 48 (N=26)-21.5 (-26.4 to -16.6)
SecondaryPercent Change in Triglycerides (TG) From Study Entry
Time frame:
Study entry and weeks 4, 12, 24, and 48
Reported as:
Mean · percentage of TG at study entry
Percent Change in Triglycerides (TG) From Study Entry
percentage of TG at study entryAtorvastatin
Percent change in TG at Week 4 (N=27)-9.5 (-20.4 to 1.4)
Percent change in TG at Week 12 (N=27)-12.6 (-19.5 to -5.7)
Percent change in TG at Week 24 (N=26)-11.3 (-22.8 to 0.2)
Percent change in TG at Week 48 (N=26)-12.6 (-22.5 to -2.7)
SecondaryPercent Change in HDL-cholesterol (HDL-C) From Study Entry
Time frame:
Study entry and weeks 4, 12, 24, and 48
Reported as:
Mean · percentage of HDL-C at study entry
Percent Change in HDL-cholesterol (HDL-C) From Study Entry
percentage of HDL-C at study entryAtorvastatin
Percent change in HDL-C at Week 4 (N=27)1.8 (-2.5 to 6.1)
Percent change in HDL-C at Week 12 (N=27)2.3 (-1.1 to 5.7)
Percent change in HDL-C at Week 24 (N=26)3.0 (-3.1 to 9.1)
Percent change in HDL-C at Week 48 (N=26)4.2 (-3.5 to 11.9)
SecondaryPercent Change in Apolipoprotein A1 (Apo A-1) From Study Entry
Time frame:
Study entry and weeks 12, 24, and 48
Reported as:
Mean · percentage of Apo A-1 at study entry
Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry
percentage of Apo A-1 at study entryAtorvastatin
Percent change in Apo A-1 at Week 12 (N=24)0.8 (-3.2 to 4.8)
Percent change in Apo A-1 at Week 24 (N=23)2.4 (-2.7 to 7.5)
Percent change in Apo A-1 at Week 48 (N=24)0.3 (-4.8 to 5.4)
SecondaryPercent Change in Apolipoprotein B (Apo B) From Study Entry
Time frame:
Study entry and weeks 12, 24, and 48
Reported as:
Mean · percentage of Apo B at study entry
Percent Change in Apolipoprotein B (Apo B) From Study Entry
percentage of Apo B at study entryAtorvastatin
Percent change in Apo B at Week 12 (N=24)-27.2 (-32.0 to -22.4)
Percent change in Apo B at Week 24 (N=23)-25.1 (-29.5 to -20.7)
Percent change in Apo B at Week 48 (N=24)-23.8 (-30.5 to -17.1)
SecondaryPercent Change in High-sensitivity CRP (Hs-CRP) From Study Entry
Time frame:
Study entry and weeks 12, 24, and 48
Reported as:
Median · percentage of hs-CRP at study entry
Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry
percentage of hs-CRP at study entryAtorvastatin
Percent change in hs-CRP at Week 12 (N=25)0 (-35 to 44)
Percent change in hs-CRP at Week 24 (N=23)-20 (-67 to 0)
Percent change in hs-CRP at Week 48 (N=24)0 (-78 to 17)
SecondaryPercent Change in Interleukin 6 (IL-6) From Study Entry
Time frame:
Study entry and weeks 12, 24, and 48
Reported as:
Median · percentage of IL-6 at study entry
Percent Change in Interleukin 6 (IL-6) From Study Entry
percentage of IL-6 at study entryAtorvastatin
Percent change in IL-6 at Week 12 (N=24)-1 (-32 to 110)
Percent change in IL-6 at Week 24 (N=23)-19 (-32 to -5)
Percent change in IL-6 at Week 48 (N=24)-11.5 (-34 to 46)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Undetectable Plasma HIV-1 RNA
percentage of participantsAtorvastatin
Week 0 (N=28)71.0 (54.0 to 85.0)
Week 12 (N=26)69.0 (51.0 to 84.0)
Week 24 (N=26)62.0 (44.0 to 77.0)
Week 48 (N=26)69.0 (51.0 to 84.0)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group
percentage of participants10 to 14 Years Old15 to 23 Years Old
Week 1214.3 (0.7 to 52.1)0 (0 to 13.3)
Week 2414.3 (0.7 to 52.1)0 (0 to 13.3)
Week 4828.6 (5.3 to 65.9)0 (0 to 13.3)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group
percentage of participants10 to 14 Years Old15 to 23 Years Old
Week 1214.3 (0.7 to 52.1)23.8 (9.9 to 43.7)
Week 2414.3 (0.7 to 52.1)23.8 (9.9 to 43.7)
Week 4828.6 (5.3 to 65.9)28.6 (13.2 to 48.7)

Adverse events

Collected over From date of Atorvastatin initiation until Week 48.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atorvastatin—3/28 (10.7%)27/28 (96.4%)
Most frequent serious events
Most frequent serious events
EventAtorvastatin
PneumoniaInfections and infestations1/28
Blood creatinine increasedInvestigations1/28
Hepatic enzyme increasedInvestigations1/28
Suicide attemptPsychiatric disorders1/28
Most frequent other events
Showing 10 of 38
Most frequent other events
EventAtorvastatin
Blood cholesterol increasedInvestigations16/28
Low density lipoprotein increasedInvestigations16/28
Blood bicarbonate decreasedInvestigations11/28
CoughRespiratory, thoracic and mediastinal disorders9/28
Alanine aminotransferase increasedInvestigations7/28
Aspartate aminotransferase increasedInvestigations7/28
Blood bilirubin increasedInvestigations6/28
Blood glucose decreasedInvestigations6/28
Neutrophil count decreasedInvestigations6/28
Nasal congestionRespiratory, thoracic and mediastinal disorders6/28

Baseline characteristics

All participants who initiated Atorvastatin were included in the baseline characteristics.

Age, Continuous
Age, Continuous(years)Atorvastatin
Mean17 ± 4
Age, Customized
Age, Customized(participants)Atorvastatin
10 - <15 years old7
15 - <19 years old12
19 - <24 years old9
Sex: Female, Male
Sex: Female, Male(Participants)Atorvastatin
Female19
Male9
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Atorvastatin
White Non-Hispanic4
Black Non-Hispanic18
Hispanic (Regardless of Race)5
Asian, Pacific Islander1
Region of Enrollment
Region of Enrollment(participants)Atorvastatin
United States28
CD4 Percent at screening, Categorical
CD4 Percent at screening, Categorical(participants)Atorvastatin
15% to <25%2
>=25%26
HIV-1 RNA, Categorical
HIV-1 RNA, Categorical(participants)Atorvastatin
>=Lower limit of quantification of assay8
<Lower limit of quantification of assay20
Antiretroviral (ARV) Regimen at entry, Categorical
Antiretroviral (ARV) Regimen at entry, Categorical(participants)Atorvastatin
At least one PI and at least one NNRTI5
At least one PI and no NNRTI17
At least one NNRTI and no PI4
Other ARV regimen2
08

Study locations

11 sites
  • Univ. of Colorado Denver NICHD CRS (5052)
    Aurora, Colorado 80045, United States
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)
    Miami, Florida 33136, United States
  • University of South Florida Tampa (5018)
    Tampa, Florida 33620, United States
  • Chicago Children's CRS (4001)
    Chicago, Illinois 60614, United States
  • Tulane University (5095)
    New Orleans, Louisiana 70112, United States
  • Boston Medical Center Ped. HIV Program NICHD CRS (5011)
    Boston, Massachusetts 02118, United States
  • Bronx-Lebanon Hospital IMPAACT CRS (6901)
    Bronx, New York 10457, United States
  • New York University NY (5012)
    New York, New York 10016, United States
  • Metropolitan Hospital (5003)
    New York, New York 10029, United States
  • St. Jude/UTHSC CRS (6501)
    Memphis, Tennessee 38105, United States
  • Texas Children's Hosp. CRS (3801)
    Houston, Texas 77030, United States
09

References and documents

Publications

  • Kamin D, Hadigan C. Hyperlipidemia in children with HIV infection: an emerging problem. Expert Rev Cardiovasc Ther. 2003 May;1(1):143-50. doi: 10.1586/14779072.1.1.143. PubMed 15030304 ↗
  • Penzak SR, Chuck SK. Management of protease inhibitor-associated hyperlipidemia. Am J Cardiovasc Drugs. 2002;2(2):91-106. doi: 10.2165/00129784-200202020-00003. PubMed 14727985 ↗
  • Solorzano Santos F, Gochicoa Rangel LG, Palacios Saucedo G, Vazquez Rosales G, Miranda Novales MG. Hypertriglyceridemia and hypercholesterolemia in human immunodeficiency virus-1-infected children treated with protease inhibitors. Arch Med Res. 2006 Jan;37(1):129-32. doi: 10.1016/j.arcmed.2005.05.013. PubMed 16314198 ↗
  • The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009)
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00663234
Lead sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Apr 22, 2008
Start date
Aug 2009
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Apr 6, 2016
Last update
Apr 6, 2016

Study contacts

Ann Melvin, MD
study chair · Seattle Children's Hospital
Marilyn Crain, MD, MPH
study chair · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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