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

3. november 2021 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Intensive Pharmacokinetic Studies of Antiretroviral Drug Combinations in Children

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

75

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Alhambra, California, Forenede Stater, 91803
        • Usc La Nichd Crs
      • La Jolla, California, Forenede Stater, 92093-0672
        • University of California, UC San Diego CRS
      • Long Beach, California, Forenede Stater, 90806
        • Miller Children's Hosp. Long Beach CA NICHD CRS
      • Torrance, California, Forenede Stater, 90502
        • Harbor UCLA Medical Ctr. NICHD CRS
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Connecticut Children's Med. Ctr.
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Pediatric Perinatal HIV Clinical Trials Unit CRS
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Univ. Cook County Hosp. Chicago NICHD CRS
      • Chicago, Illinois, Forenede Stater, 60614-3393
        • Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Univ. of Maryland Baltimore NICHD CRS
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Univ. Baltimore NICHD CRS
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Children's Hosp. of Boston NICHD CRS
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Health, Baystate Med. Ctr.
      • Worcester, Massachusetts, Forenede Stater, 01605
        • WNE Maternal Pediatric Adolescent AIDS CRS
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Children's Hospital of Michigan NICHD CRS
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07103
        • Rutgers - New Jersey Medical School CRS
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Jacobi Med. Ctr. Bronx NICHD CRS
      • Brooklyn, New York, Forenede Stater, 11203
        • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
      • New York, New York, Forenede Stater, 10016
        • Nyu Ny Nichd Crs
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • DUMC Ped. CRS
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105-3678
        • St. Jude Children's Research Hospital CRS
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Seattle Children's Hospital CRS
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • San Juan City Hosp. PR NICHD CRS
      • San Juan, Puerto Rico, 00935
        • University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: D
TDF and EFV or NVP throughout study
Medicin: Efavirenz
Dosage dependent on participant
Andre navne:
  • EFV
Medicin: Nevirapine
Dosage dependent on participant
Andre navne:
  • NVP
Medicin: Tenofovir disoproxil fumarate
300 mg orally daily
Andre navne:
  • TDF
Procedure: Pharmacokinetic Study
Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
Andre navne:
  • PK undersøgelse
Eksperimentel: E
TDF and DRV with or without EFV throughout study
Medicin: Efavirenz
Dosage dependent on participant
Andre navne:
  • EFV
Medicin: Tenofovir disoproxil fumarate
300 mg orally daily
Andre navne:
  • TDF
Procedure: Pharmacokinetic Study
Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
Andre navne:
  • PK undersøgelse
Medicin: Darunavir
300 mg or 600 mg orally twice daily
Andre navne:
  • DRV
Medicin: Ritonavir
50 mg or 100 mg orally twice daily
Andre navne:
  • RTV
Eksperimentel: F
TDF and ATV and RTV with or without EFV throughout study
Medicin: Efavirenz
Dosage dependent on participant
Andre navne:
  • EFV
Medicin: Tenofovir disoproxil fumarate
300 mg orally daily
Andre navne:
  • TDF
Procedure: Pharmacokinetic Study
Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
Andre navne:
  • PK undersøgelse
Medicin: Ritonavir
50 mg or 100 mg orally twice daily
Andre navne:
  • RTV
Medicin: Atazanavir
200 mg to 400 mg orally daily
Andre navne:
  • ATV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Predosage concentration (C0 and C12) and area under the concentration-time curve (AUC)
Tidsramme: Over the dosing interval
Over the dosing interval

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Studiestol: Jennifer King, PharmD, Department of Pharmacology and Toxicology, University of Alabama at Birmingham
  • Studiestol: Ram Yogev, MD, Section of Pediatrics and Maternal HIV Infection, Children's Memorial Hospital, Northwestern University Medical School

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2006

Primær færdiggørelse (Faktiske)

1. april 2009

Studieafslutning (Faktiske)

1. april 2009

Datoer for studieregistrering

Først indsendt

29. november 2005

Først indsendt, der opfyldte QC-kriterier

29. november 2005

Først opslået (Skøn)

1. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2021

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P1058
  • 10050 (DAIDS-ES)
  • PACTG 1058
  • IMPAACT P1058

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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