- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00273273
PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir
27. februar 2017 opdateret af: University of North Carolina, Chapel Hill
Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection
The purpose of this project is to study the pharmacokinetics of a once-daily antiretroviral medication used to treat adolescents and young adults with HIV infection.
Studieoversigt
Detaljeret beskrivelse
Once-daily antiretroviral therapy is being used to treat adolescents and young adults with HIV-1 infection.
When new antiretrovirals (ARVs) are developed, information on kinetics is collected in adults, and then in children, but often the adolescent age group is under-represented in initial or even later pharmacokinetics studies, so specific data on appropriate drug doses to use in adolescents may be lacking; it is assumed that they should receive the adult dose.
Furthermore, as newer drugs are used in combination regimens, more information becomes available on drug interactions that might not have been initially anticipated.
This information is usually generated in studies of adults, with little or no specific information in children or adolescents.
This is an open-label, 24-hour, single-dose pharmacokinetic study.
Undersøgelsestype
Observationel
Tilmelding
30
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90027
- Children's Hospital of Los Angeles
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San Diego, California, Forenede Stater, 92103
- University of California at San Diego
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San Francisco, California, Forenede Stater, 94143
- University of California at San Francisco
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Children's Diagnostic and Treatment Center
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Miami, Florida, Forenede Stater, 33101
- University of Miami
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Stroger Hospital of Cook County
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Children's Hopsital of Boston
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New York
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New York, New York, Forenede Stater, 10128
- Mount Sinai Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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San Juan, Puerto Rico, 00936
- University of Puerto Rico
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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
18 år til 25 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Persons with HIV-1 infection between the ages of 18 years, 0 days and 24 years, 364 days currently on a stable combination antiretroviral regimen (> 28 days) with FDA-approved antiretroviral combination regimens that include tenofovir plus atazanavir/ritonavir and at least one other active antiretroviral drug.
Beskrivelse
Inclusion Criteria:
- Age > 18 year to < 25 years.
- Confirmed diagnosis of HIV-1 infection defined as one positive assay supported by documentation from the subject's medical record. The result may be any of the following:
- HIV-1 DNA PCR,
- HIV-1 RNA PCR (> 5,000 copies/ml),
- Standard ELISA with confirmatory western blot performed after 18 months of age, or
- HIV culture.
- CD4 cell count: no restrictions.
- Viral load: no restrictions.
- Current treatment with stable antiretroviral combination therapy with at least 3 active drugs for a minimum of 28 days. The treatment regimen will not be started or changed for the purposes of participation in this study. Rather, this study will measure kinetics of the drugs in patients who have been receiving therapy at the direction of their treating physician.
- Regimen must be prescribed at FDA-approved doses for age.
- Regimens allowed:
- Atazanavir 300 mg po once daily plus ritonavir 100 mg po once daily, and
- Tenofovir 300 mg po once daily, plus
- At least one other antiretroviral medication prescribed at FDA-approved dose for age, excluding other protease inhibitors and NNRTIs.
- Ability and willingness to be contacted by study personnel daily for the two days prior to the pharmacokinetics visit, to take antiretroviral medicines at the same time in the morning daily for at least 3 days (one of those days being the day of the PK study visit), and ability and willingness to return to the clinic the day after the observed administered dose for a follow-up measurement of plasma drug concentration.
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Pregnancy.
- Active therapy for malignancy.
- Known presence of gastrointestinal disease that would interfere with drug administration or absorption.
- Grade 3 or higher ALT or AST.
- Grade 3 or higher Creatinine.
- Concurrent treatment with another protease inhibitor or a non-nucleoside analogue reverse transcriptase inhibitor.
- No evidence of anemia greater than Grade 1 according to the ATN Toxicity Table for Grading Severity of Adolescent Adverse Experiences (see Chapter 11 of ATN MOGO).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Measure the pharmacokinetics of atazanavir/ritonavir and tenofovir
Tidsramme: 6 Months
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To measure the pharmacokinetics of atazanavir/ritonavir and tenofovir when used in combination to treat HIV-infected adolescents and young adult subjects
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6 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Kinetics comparison
Tidsramme: 6 Months
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To compare the kinetics in these study subjects with published kinetics profiles in adults and children.
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6 Months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Peter Havens, MD, MACC Fund Research Center
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.
Hjælpsomme links
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. december 2007
Studieafslutning (Faktiske)
1. december 2007
Datoer for studieregistrering
Først indsendt
4. januar 2006
Først indsendt, der opfyldte QC-kriterier
5. januar 2006
Først opslået (Skøn)
9. januar 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. februar 2017
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- Langsomme virussygdomme
- HIV-infektioner
- Infektioner
- Erhvervet immundefektsyndrom
Andre undersøgelses-id-numre
- ATN 056
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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