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

NCT00260078 | Completed Phase 1 DMC

• 4 other identifiers: P1058PACTG 1058IMPAACT P105810050
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 23

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 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.

Conditions

HIV Infections

Keywords

Treatment Experienced; Pharmacokinetics; PK

Outcome Measures

Primary Outcomes (1)

• Predosage concentration (C0 and C12) and area under the concentration-time curve (AUC)

  Over the dosing interval

Study Arms (3)

D

EXPERIMENTAL

TDF and EFV or NVP throughout study

Drug: Efavirenz; Drug: Nevirapine; Drug: Tenofovir disoproxil fumarate; Procedure: Pharmacokinetic Study

E

EXPERIMENTAL

TDF and DRV with or without EFV throughout study

Drug: Darunavir; Drug: Efavirenz; Drug: Ritonavir; Drug: Tenofovir disoproxil fumarate; Procedure: Pharmacokinetic Study

F

EXPERIMENTAL

TDF and ATV and RTV with or without EFV throughout study

Drug: Atazanavir; Drug: Efavirenz; Drug: Ritonavir; Drug: Tenofovir disoproxil fumarate; Procedure: Pharmacokinetic Study

Interventions

Atazanavir DRUG

200 mg to 400 mg orally daily

Also known as: ATV

F

Darunavir DRUG

300 mg or 600 mg orally twice daily

Also known as: DRV

E

Efavirenz DRUG

Dosage dependent on participant

Also known as: EFV

D; E; F

Nevirapine DRUG

Dosage dependent on participant

Also known as: NVP

D

Ritonavir DRUG

50 mg or 100 mg orally twice daily

Also known as: RTV

E; F

Tenofovir disoproxil fumarate DRUG

300 mg orally daily

Also known as: TDF

D; E; F

Pharmacokinetic Study PROCEDURE

Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.

Also known as: PK Study

D; E; F

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (23)

Usc La Nichd Crs

Alhambra, California, 91803, United States

Location

University of California, UC San Diego CRS

La Jolla, California, 92093-0672, United States

Location

Miller Children's Hosp. Long Beach CA NICHD CRS

Long Beach, California, 90806, United States

Location

Harbor UCLA Medical Ctr. NICHD CRS

Torrance, California, 90502, United States

Location

Connecticut Children's Med. Ctr.

Hartford, Connecticut, 06106, United States

Location

Pediatric Perinatal HIV Clinical Trials Unit CRS

Miami, Florida, 33136, United States

Location

Rush Univ. Cook County Hosp. Chicago NICHD CRS

Chicago, Illinois, 60612, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS

Chicago, Illinois, 60614-3393, United States

Location

Univ. of Maryland Baltimore NICHD CRS

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Univ. Baltimore NICHD CRS

Baltimore, Maryland, 21287, United States

Location

Children's Hosp. of Boston NICHD CRS

Boston, Massachusetts, 02115, United States

Location

Baystate Health, Baystate Med. Ctr.

Springfield, Massachusetts, 01199, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, 01605, United States

Location

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, 48201, United States

Location

Rutgers - New Jersey Medical School CRS

Newark, New Jersey, 07103, United States

Location

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

Brooklyn, New York, 11203, United States

Location

Nyu Ny Nichd Crs

New York, New York, 10016, United States

Location

Jacobi Med. Ctr. Bronx NICHD CRS

The Bronx, New York, 10461, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27710, United States

Location

St. Jude Children's Research Hospital CRS

Memphis, Tennessee, 38105-3678, United States

Location

Seattle Children's Hospital CRS

Seattle, Washington, 98105, United States

Location

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan, 00935, Puerto Rico

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 18025112 BACKGROUND

• 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.

  PMID: 16291735 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate; Darunavir; efavirenz; Nevirapine; Ritonavir; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Thiazoles; Azoles; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jennifer King, PharmD

  Department of Pharmacology and Toxicology, University of Alabama at Birmingham

  STUDY CHAIR

• Ram Yogev, MD

  Section of Pediatrics and Maternal HIV Infection, Children's Memorial Hospital, Northwestern University Medical School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: February 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 9, 2021

Record last verified: 2016-07

Locations

US (21); PR (2)