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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00663234
Recruitment Status : Terminated (The study was prematurely discontinued due to administrative reasons.)
First Posted : April 22, 2008
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Hyperlipidemia
Intervention Drug: Atorvastatin
Enrollment 28
Recruitment Details Recruitment occurred between August 31, 2009 (date first participant enrolled) and December 16, 2013 (date last participant enrolled).
Pre-assignment Details  
Arm/Group Title Atorvastatin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 28
Dose Increased to 20 mg at Week 8 10
Completed 27
Not Completed 1
Reason Not Completed
Not willing to adhere to requirements             1
Arm/Group Title Atorvastatin
Hide Arm/Group Description 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
All participants who initiated Atorvastatin were included in the baseline characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
17  (4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
10 - <15 years old 7
15 - <19 years old 12
19 - <24 years old 9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
19
  67.9%
Male
9
  32.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
White Non-Hispanic 4
Black Non-Hispanic 18
Hispanic (Regardless of Race) 5
Asian, Pacific Islander 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
CD4 Percent at screening, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
15% to <25% 2
>=25% 26
HIV-1 RNA, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
>=Lower limit of quantification of assay 8
<Lower limit of quantification of assay 20
Antiretroviral (ARV) Regimen at entry, Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
At least one PI and at least one NNRTI 5
At least one PI and no NNRTI 17
At least one NNRTI and no PI 4
Other ARV regimen 2
[1]
Measure Description: ARV regimens are categorized based on whether or not they contain Protease Inhibitors (PIs) and/or Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs).
1.Primary Outcome
Title Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 12
3.6
(0.2 to 15.9)
Week 24
3.6
(0.2 to 15.9)
Week 48
7.1
(1.3 to 20.8)
2.Primary Outcome
Title Percentage of Participants Experiencing at Least One Adverse Event (AE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 12
21.4
(9.8 to 38.0)
Week 24
21.4
(9.8 to 38.0)
Week 48
28.6
(15.1 to 45.7)
3.Primary Outcome
Title Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
60.7
(43.5 to 76.2)
Week 12
46.4
(30.1 to 63.4)
Week 24
57.1
(40.0 to 73.1)
Week 48
53.6
(36.6 to 69.9)
4.Primary Outcome
Title Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated study treatment and have LDL-C data available at study entry and the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 27
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
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)
5.Primary Outcome
Title Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
69.2
(42.7 to 88.7)
Week 12
69.2
(42.7 to 88.7)
Week 24
84.6
(59.0 to 97.2)
Week 48
53.9
(28.7 to 77.6)
6.Primary Outcome
Title Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin and did not experience a primary safety event attributable to Atorvastatin.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
57.7
(39.8 to 74.2)
Week 12
50.0
(32.7 to 67.3)
Week 24
57.7
(39.8 to 74.2)
Week 48
53.9
(36.2 to 70.8)
7.Primary Outcome
Title Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 10 to 14 Years Old 15 to 23 Years Old
Hide Arm/Group Description:

Participants ages 10 to 14 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.

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.

Overall Number of Participants Analyzed 7 21
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
71.4
(34.1 to 94.7)
57.1
(37.2 to 75.5)
Week 12
28.6
(5.3 to 65.9)
52.4
(32.8 to 71.4)
Week 24
71.4
(34.1 to 94.7)
52.4
(32.8 to 71.4)
Week 48
71.4
(34.1 to 94.7)
47.6
(28.6 to 67.2)
8.Primary Outcome
Title Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title NNRTI-exposed NNRTI-unexposed
Hide Arm/Group Description:
Participant was on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
Participant was not on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
Overall Number of Participants Analyzed 9 19
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
66.7
(34.5 to 90.2)
57.9
(36.8 to 77.0)
Week 12
55.6
(25.1 to 83.1)
42.1
(23.0 to 63.2)
Week 24
44.4
(16.9 to 74.9)
63.2
(41.8 to 81.3)
Week 48
55.6
(25.1 to 83.1)
52.6
(32.0 to 72.6)
9.Primary Outcome
Title Percent Change in LDL Cholesterol (LDL-C) From Study Entry
Hide Description [Not Specified]
Time Frame Study entry and weeks 4, 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin and had LDL-C data available at study entry and the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 27
Mean (90% Confidence Interval)
Unit of Measure: percentage of LDL-C at study entry
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)
10.Primary Outcome
Title Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin.
Arm/Group Title 10 to 14 Years Old 15 to 23 Years Old
Hide Arm/Group Description:

Participants ages 10 to 14 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.

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.

Overall Number of Participants Analyzed 7 21
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 12
14.3
(0.7 to 52.1)
0
(0 to 13.3)
Week 24
14.3
(0.7 to 52.1)
0
(0 to 13.3)
Week 48
28.6
(5.3 to 65.9)
0
(0 to 13.3)
11.Primary Outcome
Title Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin.
Arm/Group Title 10 to 14 Years Old 15 to 23 Years Old
Hide Arm/Group Description:

Participants ages 10 to 14 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.

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.

Overall Number of Participants Analyzed 7 21
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 12
14.3
(0.7 to 52.1)
23.8
(9.9 to 43.7)
Week 24
14.3
(0.7 to 52.1)
23.8
(9.9 to 43.7)
Week 48
28.6
(5.3 to 65.9)
28.6
(13.2 to 48.7)
12.Secondary Outcome
Title Percent Change in Fasting Total Cholesterol (TC) From Study Entry
Hide Description [Not Specified]
Time Frame Study entry and weeks 4, 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin and had total cholesterol data available at study entry and the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 27
Mean (90% Confidence Interval)
Unit of Measure: percentage of TC at study entry
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)
13.Secondary Outcome
Title Percent Change in Triglycerides (TG) From Study Entry
Hide Description [Not Specified]
Time Frame Study entry and weeks 4, 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin and had triglycerides data available at study entry and the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 27
Mean (90% Confidence Interval)
Unit of Measure: percentage of TG at study entry
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)
14.Secondary Outcome
Title Percent Change in HDL-cholesterol (HDL-C) From Study Entry
Hide Description [Not Specified]
Time Frame Study entry and weeks 4, 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin and had HDL-C data available at study entry and the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 27
Mean (90% Confidence Interval)
Unit of Measure: percentage of HDL-C at study entry
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)
15.Secondary Outcome
Title Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry
Hide Description [Not Specified]
Time Frame Study entry and weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin and had Apo A-1 data available at study entry and the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 24
Mean (90% Confidence Interval)
Unit of Measure: percentage of Apo A-1 at study entry
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)
16.Secondary Outcome
Title Percent Change in Apolipoprotein B (Apo B) From Study Entry
Hide Description [Not Specified]
Time Frame Study entry and weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin and had Apo B data available at study entry and the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 24
Mean (90% Confidence Interval)
Unit of Measure: percentage of Apo B at study entry
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)
17.Secondary Outcome
Title Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry
Hide Description [Not Specified]
Time Frame Study entry and weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin and had hs-CRP data available at study entry and the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 25
Median (90% Confidence Interval)
Unit of Measure: percentage of hs-CRP at study entry
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)
18.Secondary Outcome
Title Percent Change in Interleukin 6 (IL-6) From Study Entry
Hide Description [Not Specified]
Time Frame Study entry and weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated Atorvastatin and had IL-6 data available at study entry and the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 24
Median (90% Confidence Interval)
Unit of Measure: percentage of IL-6 at study entry
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)
19.Secondary Outcome
Title Percentage of Participants With Undetectable Plasma HIV-1 RNA
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants who initiated Atorvastatin and had HIV-1 RNA data available at the specified week.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
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)
Time Frame From date of Atorvastatin initiation until Week 48.
Adverse Event Reporting Description 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.
 
Arm/Group Title Atorvastatin
Hide Arm/Group Description 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
All-Cause Mortality
Atorvastatin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Atorvastatin
Affected / at Risk (%)
Total   3/28 (10.71%) 
Infections and infestations   
Pneumonia  1  1/28 (3.57%) 
Investigations   
Blood creatinine increased  1  1/28 (3.57%) 
Hepatic enzyme increased  1  1/28 (3.57%) 
Psychiatric disorders   
Suicide attempt  1  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atorvastatin
Affected / at Risk (%)
Total   27/28 (96.43%) 
Blood and lymphatic system disorders   
Lymphadenopathy  1  2/28 (7.14%) 
Ear and labyrinth disorders   
Otorrhoea  1  2/28 (7.14%) 
Gastrointestinal disorders   
Abdominal pain  1  3/28 (10.71%) 
Nausea  1  2/28 (7.14%) 
Vomiting  1  3/28 (10.71%) 
General disorders   
Peripheral swelling  1  3/28 (10.71%) 
Pyrexia  1  4/28 (14.29%) 
Infections and infestations   
Otitis media  1  2/28 (7.14%) 
Pharyngitis  1  2/28 (7.14%) 
Investigations   
Alanine aminotransferase increased  1  7/28 (25.00%) 
Aspartate aminotransferase increased  1  7/28 (25.00%) 
Blood alkaline phosphatase increased  1  2/28 (7.14%) 
Blood bicarbonate decreased  1  11/28 (39.29%) 
Blood bilirubin increased  1  6/28 (21.43%) 
Blood calcium increased  1  2/28 (7.14%) 
Blood cholesterol increased  1  16/28 (57.14%) 
Blood glucose decreased  1  6/28 (21.43%) 
Blood glucose increased  1  2/28 (7.14%) 
Blood potassium decreased  1  3/28 (10.71%) 
Blood sodium decreased  1  5/28 (17.86%) 
Blood uric acid increased  1  2/28 (7.14%) 
Low density lipoprotein increased  1  16/28 (57.14%) 
Neutrophil count decreased  1  6/28 (21.43%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  2/28 (7.14%) 
Nervous system disorders   
Headache  1  5/28 (17.86%) 
Hypoaesthesia  1  3/28 (10.71%) 
Reproductive system and breast disorders   
Vaginal discharge  1  2/28 (7.14%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  9/28 (32.14%) 
Dyspnoea  1  3/28 (10.71%) 
Nasal congestion  1  6/28 (21.43%) 
Oropharyngeal pain  1  2/28 (7.14%) 
Pharyngeal erythema  1  2/28 (7.14%) 
Rhinorrhoea  1  6/28 (21.43%) 
Sneezing  1  2/28 (7.14%) 
Wheezing  1  3/28 (10.71%) 
Skin and subcutaneous tissue disorders   
Rash  1  2/28 (7.14%) 
Skin lesion  1  2/28 (7.14%) 
Urticaria  1  2/28 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
EMail: mallen@fhi360.org
Layout table for additonal information
Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00663234    
Other Study ID Numbers: IMPAACT P1063
U01AI068632 ( U.S. NIH Grant/Contract )
10167
First Submitted: April 21, 2008
First Posted: April 22, 2008
Results First Submitted: December 3, 2015
Results First Posted: April 6, 2016
Last Update Posted: April 6, 2016