Status:
COMPLETED
Lopinavir/Ritonavir (Kaletra) PK in Children
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
American Association of Colleges of Pharmacy
Conditions:
HIV/AIDS Treatment
HIV Infections
Eligibility:
FEMALE
6-17 years
Phase:
PHASE4
Brief Summary
The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-label, crossov...
Detailed Description
By the end of 2005, approximately 2.3 million children worldwide were living with HIV/AIDS.1 At least 660,000 children worldwide have advanced HIV/AIDS and are in dire need of antiretroviral treatment...
Eligibility Criteria
Inclusion
- Documented HIV infection
- Taking lopinavir/ritonavir (Kaletra) tablets at standard pediatric doses for greater than two weeks
- Concomitant medications and/or natural products, including potentially interacting products, have been stable for greater than two weeks and are not expected to change over the course of the study
- Ability to understand study procedures and assent to participate
- Parental or guardian consent
- Aged 6 - 17 years
Exclusion
- Acute serious medical illness or infection (in the judgment of the investigator)requiring treatment and/or hospitalization within 14 days prior to study entry
- Pregnancy
- Concomitant medications/natural products that have been started within past two weeks and/or that will be changed over the course of the study.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00810108
Start Date
June 1 2006
End Date
May 1 2009
Last Update
July 6 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Diego - Skaggs School of Pharmacy and School of Medicine
San Diego, California, United States, 92103
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010