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Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

26. juli 2006 oppdatert av: Abbott

A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering

200

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House General Practice
      • Darlinghurst, New South Wales, Australia, 2010
        • Ground Zero Medical Centre / AIDS Research Initiative
  • Forente stater
    • Arizona
      • Phoenix,, Arizona, Forente stater, 85006
        • Phoenix Body Positive
    • California
      • Beverly Hills, California, Forente stater, 90211
        • Pacific Oaks Research
      • Fountain Valley, California, Forente stater, 92708
        • Orange County Center for Special Immunology
      • Long Beach, California, Forente stater, 90813
        • Living Hope Clinical Foundation
      • Los Angeles, California, Forente stater, 90027
        • AIDS Healthcare Foundation Research Center
    • Florida
      • Altamonte Springs, Florida, Forente stater, 32701
        • IDS Research Initiative
      • Atlantis, Florida, Forente stater, 33462
        • South Florida Clinical Research
      • Fort Myers, Florida, Forente stater, 33901
        • Associates in Research
      • Ft. Lauderdale, Florida, Forente stater, 33311
        • Comprehensive Care Center
      • Ft. Lauderdale,, Florida, Forente stater, 33316
        • Gary J. Richmond, MD
      • Plantation, Florida, Forente stater, 33317
        • Morris, Sklaver, Mestre & Denney, M.D., PA
      • Safety Harbor, Florida, Forente stater, 34695
        • Health Positive
      • Tampa, Florida, Forente stater, 33614
        • Infectious Disease Research Institute, Inc.
      • Vero Beach, Florida, Forente stater, 32960
        • Treasure Coast Infectious Disease Consultants
    • Georgia
      • Atlanta, Georgia, Forente stater, 30308
        • AIDS Research Consortium of Atlanta Inc.
    • Kansas
      • Wichita,, Kansas, Forente stater, 67214
        • Donna E. Sweet, MD
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70115
        • Drs. Combs and Lutz
    • New Jersey
      • Newark, New Jersey, Forente stater, 07102-9880
        • St. Michael's Medical Center
    • New York
      • New York, New York, Forente stater, 10011
        • Polari Medical Group
    • North Carolina
      • Winston-Salem,, North Carolina, Forente stater, 27157-1042
        • Wake Forest University School of Medicine
    • Ohio
      • Akron, Ohio, Forente stater, 44304
        • Akron Infectious Disease, Inc.
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74114
        • Associates in Medical and Mental Health, P.C.
    • Oregon
      • Portland, Oregon, Forente stater, 97209-2535
        • The Research & Education Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Triangle Medical
      • Philadelphia,, Pennsylvania, Forente stater, 19107
        • Philadelphia FIGHT
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Central Texas Clinical Research
      • Houston, Texas, Forente stater, 77004
        • Joseph C. Gathe, Jr, MD
      • Houston, Texas, Forente stater, 77098
        • Southampton Medical Group
    • Virginia
      • Hampton, Virginia, Forente stater, 23666
        • Hampton Roads Medical Specialists
  • Frankrike
      • Le Kremlin Bicetre, Frankrike, 94272
        • CHU Kremlin Bicetre
      • Nice, Frankrike, 06202
        • Hôpital l'Archet
      • Paris, Frankrike, 75018
        • Hôpital Bichat
    • Cedex 10
      • Paris, Cedex 10, Frankrike, 75475
        • Hopital Saint Louis
    • Cedex 12
      • Paris, Cedex 12, Frankrike, 75571
        • Hopital Saint Antoine
    • Cedex 20
      • Paris, Cedex 20, Frankrike, 75970
        • Hôpital Tenon
  • Singapore
      • Tan Tock Seng, Singapore, 308433
        • Tan Tock Seng Hospital
  • Spania
      • Badalona, Spania, 08916
        • Hospital Germans Trías i Pujol
      • Barcelona, Spania, 08035
        • Hospital Vall d'hebrón
      • Barcelona, Spania, 08025
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spania, 08907
        • L'Hospitalet de Llobregat
      • Madrid, Spania, 28046
        • Hospital La Paz
      • Madrid, Spania, 28041
        • Hospital 12 de Octubre
      • Madrid, Spania, 28935
        • Hospital de Mostolesi
  • Storbritannia
      • E. Sussex, Storbritannia, BN2 3EW
        • Brighton General Hospital
      • London, Storbritannia, NW3 2QG
        • Royal Free Hospital
      • London, Storbritannia, SE5 9RS
        • The Caldecot Centre King's Healthcare NHS Trust
      • London, Storbritannia, SW10 9TH
        • St. Stephen's Centre Chelsea & Westminster Hospital
      • London, Storbritannia, W2 1NY
        • St. Mary Hospital
  • Tyskland
      • Frankfurt, Tyskland, D-60590
        • Klinikum J.W. Goethe Universitat
      • Koln, Tyskland, D-505924
        • Klinik I fur Innere Medizin der Universitat zu Koln

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subject is at least 18 years of age.
  • If female, subject is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: *condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) *contraceptives (oral or parenteral) for three months prior to study drug administration) *a vasectomized partner *total abstinence from sexual intercourse
  • If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) and a urine pregnancy test performed on Study Day -1 are both negative and the subject agrees to use a barrier method of contraception throughout the study.
  • Subject is not breast-feeding.
  • Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
  • Subject has no significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic or hepatic disease that would adversely affect his/her participating in this study.
  • Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), rifampin, lovastatin, simvastatin, and St. John's wort.
  • Subject agrees not to take any medication during the study, including over-the-counter medicine, herbal medications, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
  • Subject has a Karnofsky Score greater than or equal to 70
  • Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with Abbott.
  • Subject is naive to antiretroviral treatment (< 7 days ARV treatment).
  • Subject has a plasma HIV RNA level of greater than 1,000 copies/mL at screening.
  • Subject agrees to take all doses of the lopinavir/ritonavir from the bottles provided by the sponsor (rather than take doses from a personal "dosette" box).
  • Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.

Exclusion Criteria:

  • Subject has a history of an allergic reaction or significant sensitivity to lopinavir/ritonavir, tenofovir or emtricitabine or to drugs similar to study drug.
  • Subject has a recent (within the past 6 months) history of drug and/or alcohol abuse.
  • Subject has a positive result on the screening tests for drugs of abuse.
  • Subject has a history of substance abuse or psychiatric illness that could preclude adherence with the protocol.
  • Screening laboratory analyses show any of the following abnormal laboratory results: *Hemoglobin ≤ 8.0 g/dL *Absolute neutrophil count ≤ 750 cells/µL *Platelet count ≤ 50,000 per mL *ALT or AST ≥ 3.0 x Upper Limit of Normal (ULN) *Creatinine ≥ 1.5 x Upper Limit of Normal (ULN)
  • Subject has received any investigational drug within 30 days prior to study drug administration.
  • For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Abbott

Etterforskere

  • Studieleder: Scott Brun, M.D., Global Project Head, Antiviral Global Project Team

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2002

Datoer for studieregistrering

Først innsendt

15. august 2002

Først innsendt som oppfylte QC-kriteriene

16. august 2002

Først lagt ut (Anslag)

19. august 2002

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. juli 2006

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juli 2006

Sist bekreftet

1. juli 2006

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • M02-418

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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