Lopinavir/Ritonavir (Kaletra) PK in Children
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ClinicalTrials.gov Identifier: NCT00810108 |
Recruitment Status :
Completed
First Posted : December 17, 2008
Results First Posted : July 6, 2012
Last Update Posted : July 6, 2012
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Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:
American Association of Colleges of Pharmacy
Information provided by (Responsible Party):
Brookie Best, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
HIV/AIDS Treatment HIV Infections |
Intervention |
Drug: lopinavir/ritonavir (Kaletra®) tablets |
Enrollment | 12 |
Participant Flow
Recruitment Details | Subjects were recruited between August 2008 to August 2009 from the Special Immunology Program at Children' National Medical Center in Washington DC. |
Pre-assignment Details |
Arm/Group Title | Whole Then Crushed Tablets | Crushed Then Whole Tablets |
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These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2. | These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2. |
Period Title: Overall Study | ||
Started | 6 | 7 |
Completed | 5 | 7 |
Not Completed | 1 | 0 |
Reason Not Completed | ||
Withdrawal by Subject | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Whole Then Crushed Tablets | Crushed Then Whole Tablets | Total | |
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These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2. | These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2. | Total of all reporting groups | |
Overall Number of Baseline Participants | 6 | 7 | 13 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 7 participants | 13 participants | |
<=18 years |
6 100.0%
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7 100.0%
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13 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 6 participants | 7 participants | 13 participants | |
12
(10 to 16)
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13
(12 to 16)
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13
(10 to 16)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 7 participants | 13 participants | |
Female |
3 50.0%
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4 57.1%
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7 53.8%
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Male |
3 50.0%
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3 42.9%
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6 46.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 6 participants | 7 participants | 13 participants |
6 | 7 | 13 |
Outcome Measures
Adverse Events
Limitations and Caveats
The AUC of the crushed tablet administration were measured after a single dose only, rather than at steady-state; variable adherence may have impacted results.
More Information
Results Point of Contact
Name/Title: | Dr. Brookie M. Best, Associate Professor |
Organization: | University of California San Diego |
Phone: | 858-822-5550 |
EMail: | brookie@ucsd.edu |
Responsible Party: | Brookie Best, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00810108 |
Other Study ID Numbers: |
10894 |
First Submitted: | December 15, 2008 |
First Posted: | December 17, 2008 |
Results First Submitted: | April 25, 2012 |
Results First Posted: | July 6, 2012 |
Last Update Posted: | July 6, 2012 |