Lopinavir/Ritonavir (Kaletra) PK in Children

This study has been completed.

Sponsor:

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)

ClinicalTrials.gov Identifier:

NCT00810108

First received: December 15, 2008

Last updated: June 2, 2012

Last verified: June 2012

Results First Received: April 25, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	HIV/AIDS Treatment HIV Infections
Intervention:	Drug: lopinavir/ritonavir (Kaletra®) tablets

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

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

Reporting Groups

	Description
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.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Whole Then Crushed Tablets	Crushed Then Whole Tablets	Total
Number of Participants [units: participants]	6	7	13
Age [units: participants]
<=18 years	6	7	13
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: Years] Median ( Full Range )	12 ( 10 to 16 )	13 ( 12 to 16 )	13 ( 10 to 16 )
Gender [units: participants]
Female	3	4	7
Male	3	3	6
Region of Enrollment [units: participants]
United States	6	7	13

Outcome Measures

1. Primary:

Lopinavir Area Under the Curve (AUC) [ Time Frame: pre-dose, 1,2,4,6,8, and 12 hours post-dose ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information