Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

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 the following combinations of anti-HIV drugs in HIV infected chilren: tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.

Key facts

Study ID

NCT00260078

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

75

Starts

2006-02-01

Expected to finish

2009-04-01

Last updated by the study team

2021-11-09

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Usc La Nichd Crs — Alhambra, California, United States
• University of California, UC San Diego CRS — La Jolla, California, United States
• Miller Children's Hosp. Long Beach CA NICHD CRS — Long Beach, California, United States
• Harbor UCLA Medical Ctr. NICHD CRS — Torrance, California, United States
• Connecticut Children's Med. Ctr. — Hartford, Connecticut, United States
• Pediatric Perinatal HIV Clinical Trials Unit CRS — Miami, Florida, United States
• Rush Univ. Cook County Hosp. Chicago NICHD CRS — Chicago, Illinois, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS — Chicago, Illinois, United States
• Univ. of Maryland Baltimore NICHD CRS — Baltimore, Maryland, United States
• Johns Hopkins Univ. Baltimore NICHD CRS — Baltimore, Maryland, United States
• Children's Hosp. of Boston NICHD CRS — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States
• Rutgers - New Jersey Medical School CRS — Newark, New Jersey, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, United States
• Nyu Ny Nichd Crs — New York, New York, United States
• Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
• DUMC Ped. CRS — Durham, North Carolina, United States
• St. Jude Children's Research Hospital CRS — Memphis, Tennessee, United States
• Seattle Children's Hospital CRS — Seattle, Washington, United States
• University of Puerto Rico Pediatric HIV/AIDS Research Program CRS — San Juan, Puerto Rico
• San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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