Trial Outcomes & Findings for Lopinavir/Ritonavir (Kaletra) PK in Children (NCT NCT00810108)

Last Updated: 2012-07-06

Results Overview

Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

pre-dose, 1,2,4,6,8, and 12 hours post-dose

Results posted on

2012-07-06

Subjects were recruited between August 2008 to August 2009 from the Special Immunology Program at Children' National Medical Center in Washington DC.

Participant milestones
Measure	Whole Then Crushed Tablets These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.	Crushed Then Whole Tablets These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
Overall Study STARTED	6	7
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal
Measure	Whole Then Crushed Tablets These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.	Crushed Then Whole Tablets These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
Overall Study Withdrawal by Subject	1	0

Lopinavir/Ritonavir (Kaletra) PK in Children

Baseline characteristics by cohort
Measure	Whole Then Crushed Tablets n=6 Participants These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.	Crushed Then Whole Tablets n=7 Participants These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	12 Years n=5 Participants	13 Years n=7 Participants	13 Years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants

Timeframe: pre-dose, 1,2,4,6,8, and 12 hours post-dose

Population: All subjects who completed the pharmacokinetic sampling visits with whole tablet administration were analyzed

Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)

Outcome measures
Measure	All Subjects Taking Whole Tablets n=12 Participants Lopinavir AUC from all subjects taking the whole tablet	All Subjects Taking Crushed Tablets n=12 Participants Lopinavir AUC from all subjects taking the crushed tablet
Lopinavir Area Under the Curve (AUC)	144 mg*hr/L Interval 101.0 to 202.0	92 mg*hr/L Interval 79.0 to 103.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of California San Diego

Phone: 858-822-5550