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

This study has been terminated.
(The study was prematurely discontinued due to administrative reasons.)
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
ClinicalTrials.gov Identifier:
NCT00663234
First received: April 21, 2008
Last updated: March 8, 2016
Last verified: March 2016
Results First Received: December 3, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Hyperlipidemia
Intervention: Drug: Atorvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred between August 31, 2009 (date first participant enrolled) and December 16, 2013 (date last participant enrolled).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Atorvastatin  
STARTED     28  
Dose Increased to 20 mg at Week 8     10  
COMPLETED     27  
NOT COMPLETED     1  
Not willing to adhere to requirements                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who initiated Atorvastatin were included in the baseline characteristics.

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

Baseline Measures
    Atorvastatin  
Number of Participants  
[units: participants]
  28  
Age  
[units: years]
Mean (Standard Deviation)
  17  (4)  
Age, Customized  
[units: participants]
 
10 - <15 years old     7  
15 - <19 years old     12  
19 - <24 years old     9  
Gender  
[units: participants]
 
Female     19  
Male     9  
Race/Ethnicity, Customized  
[units: participants]
 
White Non-Hispanic     4  
Black Non-Hispanic     18  
Hispanic (Regardless of Race)     5  
Asian, Pacific Islander     1  
Region of Enrollment  
[units: participants]
 
United States     28  
CD4 Percent at screening, Categorical  
[units: participants]
 
15% to <25%     2  
>=25%     26  
HIV-1 RNA, Categorical  
[units: participants]
 
>=Lower limit of quantification of assay     8  
<Lower limit of quantification of assay     20  
Antiretroviral (ARV) Regimen at entry, Categorical [1]
[units: 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] ARV regimens are categorized based on whether or not they contain Protease Inhibitors (PIs) and/or Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs).



  Outcome Measures
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1.  Primary:   Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)   [ Time Frame: Study entry to weeks 12, 24, and 48 ]

2.  Primary:   Percentage of Participants Experiencing at Least One Adverse Event (AE)   [ Time Frame: Study entry to weeks 12, 24, and 48 ]

3.  Primary:   Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

4.  Primary:   Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

5.  Primary:   Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

6.  Primary:   Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

7.  Primary:   Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

8.  Primary:   Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

9.  Primary:   Percent Change in LDL Cholesterol (LDL-C) From Study Entry   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

10.  Primary:   Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group   [ Time Frame: Study entry to weeks 12, 24, and 48 ]

11.  Primary:   Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group   [ Time Frame: Study entry to weeks 12, 24, and 48 ]

12.  Secondary:   Percent Change in Fasting Total Cholesterol (TC) From Study Entry   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

13.  Secondary:   Percent Change in Triglycerides (TG) From Study Entry   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

14.  Secondary:   Percent Change in HDL-cholesterol (HDL-C) From Study Entry   [ Time Frame: Study entry and weeks 4, 12, 24, and 48 ]

15.  Secondary:   Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry   [ Time Frame: Study entry and weeks 12, 24, and 48 ]

16.  Secondary:   Percent Change in Apolipoprotein B (Apo B) From Study Entry   [ Time Frame: Study entry and weeks 12, 24, and 48 ]

17.  Secondary:   Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry   [ Time Frame: Study entry and weeks 12, 24, and 48 ]

18.  Secondary:   Percent Change in Interleukin 6 (IL-6) From Study Entry   [ Time Frame: Study entry and weeks 12, 24, and 48 ]

19.  Secondary:   Percentage of Participants With Undetectable Plasma HIV-1 RNA   [ Time Frame: Study entry and weeks 12, 24, and 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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).


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
phone: (919) 405-1429
e-mail: mallen@fhi360.org


Publications:

Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00663234     History of Changes
Other Study ID Numbers: IMPAACT P1063
U01AI068632 ( US NIH Grant/Contract Award Number )
10167
Study First Received: April 21, 2008
Results First Received: December 3, 2015
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration