Status:
COMPLETED
Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
8-17 years
Phase:
PHASE1
PHASE2
Brief Summary
Limited data exist about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of...
Detailed Description
Because all of the available non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs) are metabolized by and affect hepatic cytochrome enzymes, combinations of two or mor...
Eligibility Criteria
Inclusion
- Note: The original Groups A, B, and C have been removed, and Groups D, E, and F have been added per protocol amendment dated 11/16/07.
- HIV infected
- Currently receiving or about to initiate one of the following anti-HIV regimens: TDF with EFV or NVP, TDF and DRV/r with or without EFV, or TDF with ATV/r with or without EFV
- Body surface area at least 0.85 m2
- Parent or guardian willing and able to provide signed informed consent
- Willing to use acceptable forms of contraception
Exclusion
- Liver disease that may affect the metabolism of study drugs
- Certain abnormal laboratory values
- Require certain medications
- Treatment with any anti-HIV or nonantiretroviral drug that could interact with drugs under PK study in the 14 days prior to study entry
- Any clinical or laboratory toxicity of Grade 4 or higher at screening. More information on this criterion can be found in the protocol.
- Pregnant or breastfeeding
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00260078
Start Date
February 1 2006
End Date
April 1 2009
Last Update
November 9 2021
Active Locations (23)
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1
Usc La Nichd Crs
Alhambra, California, United States, 91803
2
University of California, UC San Diego CRS
La Jolla, California, United States, 92093-0672
3
Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States, 90806
4
Harbor UCLA Medical Ctr. NICHD CRS
Torrance, California, United States, 90502