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Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection
The purpose of this project is to study the pharmacokinetics of a once-daily antiretroviral medication used to treat adolescents and young adults with HIV infection.
Once-daily antiretroviral therapy is being used to treat adolescents and young adults with HIV-1 infection. When new antiretrovirals (ARVs) are developed, information on kinetics is collected in adults, and then in children, but often the adolescent age group is under-represented in initial or even later pharmacokinetics studies, so specific data on appropriate drug doses to use in adolescents may be lacking; it is assumed that they should receive the adult dose. Furthermore, as newer drugs are used in combination regimens, more information becomes available on drug interactions that might not have been initially anticipated. This information is usually generated in studies of adults, with little or no specific information in children or adolescents. This is an open-label, 24-hour, single-dose pharmacokinetic study.
Age
18 - 25 years
Sex
ALL
Healthy Volunteers
Yes
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California at San Diego
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
Stroger Hospital of Cook County
Chicago, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Children's Hopsital of Boston
Boston, Massachusetts, United States
Mount Sinai Hospital
New York, New York, United States
Start Date
February 1, 2006
Primary Completion Date
December 1, 2007
Completion Date
December 1, 2007
Last Updated
February 28, 2017
30
Estimated participants
blood draw
PROCEDURE
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborators
NCT06694805
NCT04142047
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330