Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children
NCT ID: NCT00260078
Last Updated: 2021-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2006-02-28
2009-04-30
Brief Summary
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Detailed Description
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This study will last between 1 and 7 weeks. Participants in this study will be grouped based on the treatment regimen they are receiving or about to initiate. There are three groups in this study. Group D participants will receive TDF and EFV or NVP; Group E participants will receive TDF and DRV with or without EFV; and Group F participants will receive TDF and RTV with or without EFV. The inclusion of EFV or NVP will be dependent on each participant's prescribed regimen. Participants within each group will be stratified by age and how long they have been receiving their anti-HIV regimens. Antiretrovirals will not be provided by this study.
Most participants will have two study visits. The first visit will occur at study entry. Medical history, a physical exam, and blood collection will occur. The second visit will occur within 35 days of study entry and will take approximately 24 hours. Blood collection for PK studies, a physical exam, and medical history will be done at this visit. Urine collection will occur at all visits for female participants.
Participants will undergo PK testing at least 14 days after initiating their study regimens. Participants will be given a dose of their anti-HIV medications with food. A blood sample will be taken before dosing. Blood samples will also be taken at 1, 2, 4, 6, 8, 12, and 24 hours after dosing. Participants in Groups E and F may need to repeat PK testing within 6 weeks of initial PK testing at the discretion of the investigator.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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D
TDF and EFV or NVP throughout study
Efavirenz
Dosage dependent on participant
Nevirapine
Dosage dependent on participant
Tenofovir disoproxil fumarate
300 mg orally daily
Pharmacokinetic Study
Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
E
TDF and DRV with or without EFV throughout study
Darunavir
300 mg or 600 mg orally twice daily
Efavirenz
Dosage dependent on participant
Ritonavir
50 mg or 100 mg orally twice daily
Tenofovir disoproxil fumarate
300 mg orally daily
Pharmacokinetic Study
Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
F
TDF and ATV and RTV with or without EFV throughout study
Atazanavir
200 mg to 400 mg orally daily
Efavirenz
Dosage dependent on participant
Ritonavir
50 mg or 100 mg orally twice daily
Tenofovir disoproxil fumarate
300 mg orally daily
Pharmacokinetic Study
Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
Interventions
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Atazanavir
200 mg to 400 mg orally daily
Darunavir
300 mg or 600 mg orally twice daily
Efavirenz
Dosage dependent on participant
Nevirapine
Dosage dependent on participant
Ritonavir
50 mg or 100 mg orally twice daily
Tenofovir disoproxil fumarate
300 mg orally daily
Pharmacokinetic Study
Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
8 Years
17 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Jennifer King, PharmD
Role: STUDY_CHAIR
Department of Pharmacology and Toxicology, University of Alabama at Birmingham
Ram Yogev, MD
Role: STUDY_CHAIR
Section of Pediatrics and Maternal HIV Infection, Children's Memorial Hospital, Northwestern University Medical School
Locations
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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
Countries
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References
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Kiser JJ, Fletcher CV, Flynn PM, Cunningham CK, Wilson CM, Kapogiannis BG, Major-Wilson H, Viani RM, Liu NX, Muenz LR, Harris DR, Havens PL; Adolescent Trials Network for HIV/AIDS Interventions. Pharmacokinetics of antiretroviral regimens containing tenofovir disoproxil fumarate and atazanavir-ritonavir in adolescents and young adults with human immunodeficiency virus infection. Antimicrob Agents Chemother. 2008 Feb;52(2):631-7. doi: 10.1128/AAC.00761-07. Epub 2007 Nov 19.
Hazra R, Gafni RI, Maldarelli F, Balis FM, Tullio AN, DeCarlo E, Worrell CJ, Steinberg SM, Flaherty J, Yale K, Kearney BP, Zeichner SL. Tenofovir disoproxil fumarate and an optimized background regimen of antiretroviral agents as salvage therapy for pediatric HIV infection. Pediatrics. 2005 Dec;116(6):e846-54. doi: 10.1542/peds.2005-0975. Epub 2005 Nov 15.
Other Identifiers
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PACTG 1058
Identifier Type: -
Identifier Source: secondary_id
IMPAACT P1058
Identifier Type: -
Identifier Source: secondary_id
10050
Identifier Type: REGISTRY
Identifier Source: secondary_id
P1058
Identifier Type: -
Identifier Source: org_study_id