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NCT00260078 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Intensive Pharmacokinetic Studies of Antiretroviral Drug Combinations in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00260078
Other study ID # P1058
Secondary ID PACTG 1058IMPAAC
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date February 2006
Est. completion date April 2009

Study information
Verified date July 2016
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.

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 more of these drugs produce complex pharmacokinetic (PK) interactions. However, little data exist regarding PK of anti-HIV drug combinations in the pediatric population. The purpose of this study is to assess steady-state PK of the following anti-HIV regimens: TDF and EFV or NVP; TDF and DRV with or without EFV; and TDF and RTV with or without EFV. In addition, this study will evaluate how age, length of treatment, adverse effects, and genes affect children's response to different anti-HIV combinations. 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 8 Years to 17 Years
Eligibility 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. Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
Procedure:
• Pharmacokinetic Study
Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.

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

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

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. Epub 2005 Nov 15. — View Citation

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. Epub 2007 Nov 19. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Predosage concentration (C0 and C12) and area under the concentration-time curve (AUC) Over the dosing interval
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