Trial Outcomes & Findings for IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia (NCT NCT00663234)
NCT ID: NCT00663234
Last Updated: 2016-04-06
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Study entry to weeks 12, 24, and 48
Results posted on
2016-04-06
Participant Flow
Recruitment occurred between August 31, 2009 (date first participant enrolled) and December 16, 2013 (date last participant enrolled).
Participant milestones
| Measure |
Atorvastatin
10 mg to 20 mg atorvastatin taken orally once daily. Dosage starts at 10 mg and is increased to 20 mg at week 8 if efficacy criteria is not met at week 4.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
Dose Increased to 20 mg at Week 8
|
10
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Atorvastatin
10 mg to 20 mg atorvastatin taken orally once daily. Dosage starts at 10 mg and is increased to 20 mg at week 8 if efficacy criteria is not met at week 4.
|
|---|---|
|
Overall Study
Not willing to adhere to requirements
|
1
|
Baseline Characteristics
IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=28 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|
|
Age, Continuous
|
17 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Age, Customized
10 - <15 years old
|
7 participants
n=5 Participants
|
|
Age, Customized
15 - <19 years old
|
12 participants
n=5 Participants
|
|
Age, Customized
19 - <24 years old
|
9 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Regardless of Race)
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
CD4 Percent at screening, Categorical
15% to <25%
|
2 participants
n=5 Participants
|
|
CD4 Percent at screening, Categorical
>=25%
|
26 participants
n=5 Participants
|
|
HIV-1 RNA, Categorical
>=Lower limit of quantification of assay
|
8 participants
n=5 Participants
|
|
HIV-1 RNA, Categorical
<Lower limit of quantification of assay
|
20 participants
n=5 Participants
|
|
Antiretroviral (ARV) Regimen at entry, Categorical
At least one PI and at least one NNRTI
|
5 participants
n=5 Participants
|
|
Antiretroviral (ARV) Regimen at entry, Categorical
At least one PI and no NNRTI
|
17 participants
n=5 Participants
|
|
Antiretroviral (ARV) Regimen at entry, Categorical
At least one NNRTI and no PI
|
4 participants
n=5 Participants
|
|
Antiretroviral (ARV) Regimen at entry, Categorical
Other ARV regimen
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study entry to weeks 12, 24, and 48Population: All participants who initiated Atorvastatin.
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.
Outcome measures
| Measure |
Atorvastatin
n=28 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)
Week 12
|
3.6 percentage of participants
Interval 0.2 to 15.9
|
—
|
|
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)
Week 24
|
3.6 percentage of participants
Interval 0.2 to 15.9
|
—
|
|
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)
Week 48
|
7.1 percentage of participants
Interval 1.3 to 20.8
|
—
|
PRIMARY outcome
Timeframe: Study entry to weeks 12, 24, and 48Population: All participants who initiated Atorvastatin.
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.
Outcome measures
| Measure |
Atorvastatin
n=28 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants Experiencing at Least One Adverse Event (AE)
Week 12
|
21.4 percentage of participants
Interval 9.8 to 38.0
|
—
|
|
Percentage of Participants Experiencing at Least One Adverse Event (AE)
Week 24
|
21.4 percentage of participants
Interval 9.8 to 38.0
|
—
|
|
Percentage of Participants Experiencing at Least One Adverse Event (AE)
Week 48
|
28.6 percentage of participants
Interval 15.1 to 45.7
|
—
|
PRIMARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: 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.
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.
Outcome measures
| Measure |
Atorvastatin
n=28 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)
Week 4
|
60.7 percentage of participants
Interval 43.5 to 76.2
|
—
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)
Week 12
|
46.4 percentage of participants
Interval 30.1 to 63.4
|
—
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)
Week 24
|
57.1 percentage of participants
Interval 40.0 to 73.1
|
—
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)
Week 48
|
53.6 percentage of participants
Interval 36.6 to 69.9
|
—
|
PRIMARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: All participants who initiated study treatment and have LDL-C data available at study entry and the specified week.
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.
Outcome measures
| Measure |
Atorvastatin
n=27 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)
Week 4 (N=27)
|
63.0 percentage of participants
Interval 45.3 to 78.3
|
—
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)
Week 12 (N=27)
|
48.2 percentage of participants
Interval 31.3 to 65.3
|
—
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)
Week 24 (N=26)
|
61.5 percentage of participants
Interval 43.6 to 77.4
|
—
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)
Week 48 (N=26)
|
57.7 percentage of participants
Interval 39.8 to 74.2
|
—
|
PRIMARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: 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).
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.
Outcome measures
| Measure |
Atorvastatin
n=13 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)
Week 4
|
69.2 percentage of participants
Interval 42.7 to 88.7
|
—
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)
Week 12
|
69.2 percentage of participants
Interval 42.7 to 88.7
|
—
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)
Week 24
|
84.6 percentage of participants
Interval 59.0 to 97.2
|
—
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)
Week 48
|
53.9 percentage of participants
Interval 28.7 to 77.6
|
—
|
PRIMARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: All participants who initiated Atorvastatin and did not experience a primary safety event attributable to Atorvastatin.
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.
Outcome measures
| Measure |
Atorvastatin
n=26 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
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
Interval 39.8 to 74.2
|
—
|
|
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
Interval 32.7 to 67.3
|
—
|
|
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
Interval 39.8 to 74.2
|
—
|
|
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
Interval 36.2 to 70.8
|
—
|
PRIMARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: 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.
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.
Outcome measures
| Measure |
Atorvastatin
n=7 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
n=21 Participants
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group
Week 4
|
71.4 percentage of participants
Interval 34.1 to 94.7
|
57.1 percentage of participants
Interval 37.2 to 75.5
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group
Week 12
|
28.6 percentage of participants
Interval 5.3 to 65.9
|
52.4 percentage of participants
Interval 32.8 to 71.4
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group
Week 24
|
71.4 percentage of participants
Interval 34.1 to 94.7
|
52.4 percentage of participants
Interval 32.8 to 71.4
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group
Week 48
|
71.4 percentage of participants
Interval 34.1 to 94.7
|
47.6 percentage of participants
Interval 28.6 to 67.2
|
PRIMARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: 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.
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.
Outcome measures
| Measure |
Atorvastatin
n=9 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
n=19 Participants
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment
Week 4
|
66.7 percentage of participants
Interval 34.5 to 90.2
|
57.9 percentage of participants
Interval 36.8 to 77.0
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment
Week 12
|
55.6 percentage of participants
Interval 25.1 to 83.1
|
42.1 percentage of participants
Interval 23.0 to 63.2
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment
Week 24
|
44.4 percentage of participants
Interval 16.9 to 74.9
|
63.2 percentage of participants
Interval 41.8 to 81.3
|
|
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment
Week 48
|
55.6 percentage of participants
Interval 25.1 to 83.1
|
52.6 percentage of participants
Interval 32.0 to 72.6
|
PRIMARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: All participants who initiated Atorvastatin and had LDL-C data available at study entry and the specified week.
Outcome measures
| Measure |
Atorvastatin
n=27 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
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
Interval -34.6 to -26.1
|
—
|
|
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
Interval -32.4 to -20.5
|
—
|
|
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
Interval -32.7 to -23.4
|
—
|
|
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
Interval -33.1 to -19.7
|
—
|
PRIMARY outcome
Timeframe: Study entry to weeks 12, 24, and 48Population: All participants who initiated Atorvastatin.
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.
Outcome measures
| Measure |
Atorvastatin
n=7 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
n=21 Participants
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group
Week 12
|
14.3 percentage of participants
Interval 0.7 to 52.1
|
0 percentage of participants
Interval 0.0 to 13.3
|
|
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group
Week 24
|
14.3 percentage of participants
Interval 0.7 to 52.1
|
0 percentage of participants
Interval 0.0 to 13.3
|
|
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group
Week 48
|
28.6 percentage of participants
Interval 5.3 to 65.9
|
0 percentage of participants
Interval 0.0 to 13.3
|
PRIMARY outcome
Timeframe: Study entry to weeks 12, 24, and 48Population: All participants who initiated Atorvastatin.
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.
Outcome measures
| Measure |
Atorvastatin
n=7 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
n=21 Participants
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group
Week 48
|
28.6 percentage of participants
Interval 5.3 to 65.9
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
|
Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group
Week 12
|
14.3 percentage of participants
Interval 0.7 to 52.1
|
23.8 percentage of participants
Interval 9.9 to 43.7
|
|
Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group
Week 24
|
14.3 percentage of participants
Interval 0.7 to 52.1
|
23.8 percentage of participants
Interval 9.9 to 43.7
|
SECONDARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: All participants who initiated Atorvastatin and had total cholesterol data available at study entry and the specified week.
Outcome measures
| Measure |
Atorvastatin
n=27 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
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
Interval -26.8 to -20.8
|
—
|
|
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
Interval -25.1 to -17.1
|
—
|
|
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
Interval -26.0 to -19.0
|
—
|
|
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
Interval -26.4 to -16.6
|
—
|
SECONDARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: All participants who initiated Atorvastatin and had triglycerides data available at study entry and the specified week.
Outcome measures
| Measure |
Atorvastatin
n=27 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
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
Interval -20.4 to 1.4
|
—
|
|
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
Interval -19.5 to -5.7
|
—
|
|
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
Interval -22.8 to 0.2
|
—
|
|
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
Interval -22.5 to -2.7
|
—
|
SECONDARY outcome
Timeframe: Study entry and weeks 4, 12, 24, and 48Population: All participants who initiated Atorvastatin and had HDL-C data available at study entry and the specified week.
Outcome measures
| Measure |
Atorvastatin
n=27 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
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
Interval -2.5 to 6.1
|
—
|
|
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
Interval -1.1 to 5.7
|
—
|
|
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
Interval -3.1 to 9.1
|
—
|
|
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
Interval -3.5 to 11.9
|
—
|
SECONDARY outcome
Timeframe: Study entry and weeks 12, 24, and 48Population: All participants who initiated Atorvastatin and had Apo A-1 data available at study entry and the specified week.
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
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
Interval -3.2 to 4.8
|
—
|
|
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
Interval -2.7 to 7.5
|
—
|
|
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
Interval -4.8 to 5.4
|
—
|
SECONDARY outcome
Timeframe: Study entry and weeks 12, 24, and 48Population: All participants who initiated Atorvastatin and had Apo B data available at study entry and the specified week.
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
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
Interval -32.0 to -22.4
|
—
|
|
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
Interval -29.5 to -20.7
|
—
|
|
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
Interval -30.5 to -17.1
|
—
|
SECONDARY outcome
Timeframe: Study entry and weeks 12, 24, and 48Population: All participants who initiated Atorvastatin and had hs-CRP data available at study entry and the specified week.
Outcome measures
| Measure |
Atorvastatin
n=25 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
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
Interval -35.0 to 44.0
|
—
|
|
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
Interval -67.0 to 0.0
|
—
|
|
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
Interval -78.0 to 17.0
|
—
|
SECONDARY outcome
Timeframe: Study entry and weeks 12, 24, and 48Population: All participants who initiated Atorvastatin and had IL-6 data available at study entry and the specified week.
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
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
Interval -32.0 to 110.0
|
—
|
|
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
Interval -32.0 to -5.0
|
—
|
|
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
Interval -34.0 to 46.0
|
—
|
SECONDARY outcome
Timeframe: Study entry and weeks 12, 24, and 48Population: All study participants who initiated Atorvastatin and had HIV-1 RNA data available at the specified week.
Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used.
Outcome measures
| Measure |
Atorvastatin
n=28 Participants
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
15 to 23 Years Old
Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|---|
|
Percentage of Participants With Undetectable Plasma HIV-1 RNA
Week 0 (N=28)
|
71.0 percentage of participants
Interval 54.0 to 85.0
|
—
|
|
Percentage of Participants With Undetectable Plasma HIV-1 RNA
Week 12 (N=26)
|
69.0 percentage of participants
Interval 51.0 to 84.0
|
—
|
|
Percentage of Participants With Undetectable Plasma HIV-1 RNA
Week 24 (N=26)
|
62.0 percentage of participants
Interval 44.0 to 77.0
|
—
|
|
Percentage of Participants With Undetectable Plasma HIV-1 RNA
Week 48 (N=26)
|
69.0 percentage of participants
Interval 51.0 to 84.0
|
—
|
Adverse Events
Atorvastatin
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin
n=28 participants at risk
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood creatinine increased
|
3.6%
1/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Hepatic enzyme increased
|
3.6%
1/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Psychiatric disorders
Suicide attempt
|
3.6%
1/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
Other adverse events
| Measure |
Atorvastatin
n=28 participants at risk
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Ear and labyrinth disorders
Otorrhoea
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.7%
3/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
3/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
General disorders
Peripheral swelling
|
10.7%
3/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
General disorders
Pyrexia
|
14.3%
4/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Infections and infestations
Otitis media
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Infections and infestations
Pharyngitis
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
7/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
7/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood bicarbonate decreased
|
39.3%
11/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood bilirubin increased
|
21.4%
6/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood calcium increased
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood cholesterol increased
|
57.1%
16/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood glucose decreased
|
21.4%
6/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood glucose increased
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood potassium decreased
|
10.7%
3/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood sodium decreased
|
17.9%
5/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Blood uric acid increased
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Low density lipoprotein increased
|
57.1%
16/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Neutrophil count decreased
|
21.4%
6/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Nervous system disorders
Headache
|
17.9%
5/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Nervous system disorders
Hypoaesthesia
|
10.7%
3/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.1%
9/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.7%
3/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
21.4%
6/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
21.4%
6/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.7%
3/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
2/28 • From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
Additional Information
Melissa Allen, Director, IMPAACT Operations Center
Family Health International (FHI 360)
Phone: (919) 405-1429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER