A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01172535
First received: July 28, 2010
Last updated: November 16, 2015
Last verified: November 2015
Results First Received: November 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: Lopinavir/ritonavir

  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
There were 97 participants enrolled from 19 clinical sites in four countries. There were 57 participants on the liquid formulation and 40 on tablet. Accrual took place from May 20, 2011 through June 19, 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
HIV-infected infants and children ≥3 to <25 kg had to be LPV/r-treatment naïve. Children ≥10 kg had to demonstrate ability and willingness to swallow tablets. Participants were stratified by weight and drug formulation (liquid vs. tablet).

Reporting Groups
  Description
Lopinavir/Ritonavir Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.

Participant Flow:   Overall Study
    Lopinavir/Ritonavir  
STARTED     97  
COMPLETED     89  
NOT COMPLETED     8  
Death                 3  
Withdrawal by Subject                 2  
Lost to Follow-up                 1  
Ineligible at study entry                 1  
Unwilling to adhere to study requirement                 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 enrolled in the study

Reporting Groups
  Description
Lopinavir/Ritonavir Participants receiving lopinavir/ritonavirr, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.

Baseline Measures
    Lopinavir/Ritonavir  
Number of Participants  
[units: participants]
  97  
Age  
[units: years]
Median (Inter-Quartile Range)
  2.5  
  (0.5 to 6.2)  
Gender  
[units: participants]
 
Female     54  
Male     43  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     31  
Not Hispanic or Latino     42  
Unknown or Not Reported     24  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     37  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     39  
White     7  
More than one race     0  
Unknown or Not Reported     14  
Region of Enrollment  
[units: participants]
 
United States     5  
Brazil     32  
South Africa     23  
Thailand     37  
HIV RNA (copies/mL) at study entry  
[units: log copies/mL]
Median (Inter-Quartile Range)
  5.2  
  (4.6 to 5.7)  
CD4% at study entry  
[units: percentage of total lymphocytes]
Median (Inter-Quartile Range)
  24.2  
  (15.8 to 29.0)  



  Outcome Measures
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1.  Primary:   Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24)   [ Time Frame: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose ]

2.  Primary:   Maximum Concentration of Lopinavir/Ritonavir (Cmax)   [ Time Frame: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose ]

3.  Primary:   Minimum Concentration of Lopinavir/Ritonavir (Cmin)   [ Time Frame: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose ]

4.  Primary:   Clearance of Lopinavir/Ritonavir (CL/F)   [ Time Frame: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose ]

5.  Primary:   Proportion of Participants With an AUC of Less Than 10% of Adults   [ Time Frame: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose ]

6.  Primary:   Number of Participants Experiencing Adverse Events of Grade 3 or 4   [ Time Frame: Measured at study visits through end of study (weeks 2, 4, 12, 24) ]

7.  Primary:   Proportion of Participants Tolerating LPV/r   [ Time Frame: Measured at study completion (week 24) ]

8.  Secondary:   Adherence   [ Time Frame: Measured at week 4, week 12, and study completion (week 24) ]

9.  Secondary:   Treatment Efficacy (HIV Viral Load)   [ Time Frame: Measured at entry and study completion (week 24) ]

10.  Secondary:   Treatment Efficacy (CD4%)   [ Time Frame: Measured at entry and study completion (week 24) ]


  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
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  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



Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01172535     History of Changes
Obsolete Identifiers: NCT01338038
Other Study ID Numbers: P1083
10787 ( Registry Identifier: DAIDS ES )
IMPAACT P1083
Study First Received: July 28, 2010
Results First Received: November 16, 2015
Last Updated: November 16, 2015
Health Authority: United States: Food and Drug Administration