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Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

4. april 2017 opdateret af: Bristol-Myers Squibb

Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Provide study drug for patients rolling off BMS ATV clinical trials in countries where these medications are not commercially available.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

710

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1181
        • Local Institution
      • Buenos Aires, Argentina, 1155
        • Local Institution
      • Buenos Aires, Argentina, 1650
        • Local Institution
      • Buenos Aires, Argentina, 1202
        • Local Institution
      • Cordoba, Argentina, X5000BJH
        • Local Institution
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Local Institution
  • Brasilien
      • Rio De Janeiro, Brasilien, 21040000
        • Local Institution
      • Sao Paulo, Brasilien, 01246
        • Local Institution
    • Parana
      • Curitiba, Parana, Brasilien, 80060
        • Local Institution
      • Curitiba, Parana, Brasilien, 80240
        • Local Institution
    • Pernambuco
      • Recife, Pernambuco, Brasilien, 52052
        • Local Institution
    • Rio De Janeiro
      • Rio De Janeiro - Rj, Rio De Janeiro, Brasilien, 22271
        • Local Institution
    • Sao Paulo
      • Campinas, Sao Paulo, Brasilien, 13083
        • Local Institution
      • Sao Paulo - Sp, Sao Paulo, Brasilien, 01246
        • Local Institution
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H2L 5B1
        • Local Institution
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Local Institution
      • Santiago De Chile, Metropolitana, Chile
        • Local Institution
  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Local Institution
  • Costa Rica
    • Barrio Aranjuez
      • San Jose, Barrio Aranjuez, Costa Rica, 1792
        • Local Institution
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 111123
        • Local Institution
      • St. Petersburg, Den Russiske Føderation, 189635
        • Local Institution
      • St.petersburg, Den Russiske Føderation, 193167
        • Local Institution
  • Dominikanske republik
      • Santo Domingo, Dominikanske republik
        • Local Institution
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Phoenix Body Positive, Inc
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • Rand Schrader Clinic
      • San Francisco, California, Forenede Stater, 94109
        • St Francis Memorial Hospital
    • Florida
      • Miami Beach, Florida, Forenede Stater, 33139
        • Sbma Research, Llc
      • Tampa, Florida, Forenede Stater, 33607
        • St Josephs Cmprhnsv Rsch Inst
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46218
        • Infectious Disease Of Indiana, Psc
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Univ Of Kansas Sch Of Med
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • CRI of New England
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • University of Nebraska Medical Center
    • North Carolina
      • Huntersville, North Carolina, Forenede Stater, 28078
        • Jemsek Clinic
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Tarrant County Inf Dis Assoc
      • Houston, Texas, Forenede Stater, 77098
        • The Schrader Clinic
  • Frankrig
      • Le Kremlin Bicetre, Frankrig, 94275
        • Local Institution
      • Lyon Cedex 02, Frankrig, 69288
        • Local Institution
      • Paris, Frankrig, 75020
        • Local Institution
      • Paris, Frankrig, 75014
        • Local Institution
      • Tourcoing, Frankrig, 59208
        • Local Institution
  • Guatemala
      • Guatemala, Guatemala
        • Local Institution
      • Guatemala, Guatemala, 01011
        • Local Institution
      • Guatemala, Guatemala, 01016
        • Local Institution
  • Indonesien
      • Jakarta, Indonesien, 10430
        • Local Institution
  • Italien
      • Milano, Italien, 20127
        • Local Institution
      • Milano, Italien, 20157
        • Local Institution
      • Modena, Italien, 41100
        • Local Institution
      • Roma, Italien, 00185
        • Local Institution
      • Torino, Italien, 10149
        • Local Institution
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Local Institution
      • Kuala Lumpur, Malaysia, 59100
        • Local Institution
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • Local Institution
      • Mexico, Distrito Federal, Mexico, 03100
        • Local Institution
  • Panama
      • Panama, Panama, 4746
        • Local Institution
  • Peru
      • Lima, Peru, 1
        • Local Institution
      • Lima, Peru, 31
        • Local Institution
      • Lima, Peru, 13
        • Local Institution
      • Lima, Peru, LIMA 14
        • Local Institution
    • Lima
      • Barranco, Lima, Peru, 4
        • Local Institution
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Local Institution
      • Porto, Portugal, 4200-319
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico, Inc.
      • San Juan, Puerto Rico, 00927
        • V.A. Medical Center
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution
  • Spanien
      • Badalona, Spanien, 08915
        • Local Institution
      • Barcelona, Spanien, 08036
        • Local Institution
      • Bilbao, Spanien, 48013
        • Local Institution
      • Cordoba, Spanien, 14004
        • Local Institution
      • Madrid, Spanien, 28034
        • Local Institution
      • Madrid, Spanien, 28046
        • Local Institution
      • Madrid, Spanien, 28040
        • Local Institution
      • Madrid, Spanien, 28029
        • Local Institution
      • Sevilla, Spanien, 41013
        • Local Institution
  • Sydafrika
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, Sydafrika, 6001
        • Local Institution
    • Free State
      • Bloemfontein, Free State, Sydafrika, 9301
        • Local Institution
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 2013
        • Local Institution
      • Meadowdale, Gauteng, Sydafrika, 1610
        • Local Institution
      • Westdene, Gauteng, Sydafrika, 2092
        • Local Institution
    • Western Cape
      • Observatory, Western Cape, Sydafrika, 7925
        • Local Institution
      • Rugby, Western Cape, Sydafrika, 7405
        • Local Institution
  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Local Institution
      • Taipei, Taiwan, 100
        • Local Institution
      • Taipei, Taiwan, 108
        • Local Institution
  • Thailand
      • Bangkok, Thailand, 10400
        • Local Institution
      • Bangkok, Thailand, 10700
        • Local Institution
      • Bangkok, Thailand, 10300
        • Local Institution
      • Chiangmai, Thailand, 50200
        • Local Institution
  • Ungarn
      • Budapest, Ungarn, 1097
        • Local Institution

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

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects must provide written informed consent

  • Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or tenofovir-emtricitabine at time of screening and viral load is

    ≤ 10,000 copies/mL while on therapy

  • Subjects who are receiving investigational antiretroviral agents through Expanded Access Programs will be allowed to participate following discussion and approval by the BMS Medical Monitor
  • ≥ 16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate)
  • Both females of child-bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted diseases, including HIV. Other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study
  • WOCBP using a prohibited contraceptive method (no contraceptive methods prohibited in this study. However, caution is warranted with coadministration of oral contraceptives)
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from AI424182, who may still have a positive β-HCG test at the time of enrollment
  • All subjects previously discontinued from an atazanavir study for any reason
  • Active alcohol or substance abuse sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
  • Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing requirements
  • Any of the following laboratory values:
  • a) Serum creatinine ≥ 1.5 times the upper limit of normal,
  • b) Liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,
  • Hypersensitivity to any component of the formulation of study drug
  • Refer to Section 6.4.1 which details all prohibited therapies
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Atazanavir
Medicin: Atazanavir
Tablets, Oral, 400 mg, once daily, indefinitely
Andre navne:
  • Reyataz
  • BMS-232632
Eksperimentel: Atazanavir/Ritonavir
Medicin: Atazanavir/Ritonavir
Tablets, Oral, 300/100 mg, once daily, indefinitely
Andre navne:
  • Reyataz
  • BMS-232632
Aktiv komparator: Lopinavir/Ritonavir
Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
Medicin: Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, once daily, indefinitely
Andre navne:
  • Truvada
Medicin: Lopinavir/ritonavir
Tablets, Oral, 400/100 mg, twice daily, indefinitely

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death
Tidsramme: Date of First Dose to 30 days post the last dose; approximately 405 weeks)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.
Date of First Dose to 30 days post the last dose; approximately 405 weeks)

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

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. oktober 2002

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

20. oktober 2009

Først indsendt, der opfyldte QC-kriterier

28. oktober 2009

Først opslået (Skøn)

29. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AI424-077

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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Sponsorer og samarbejdspartnere

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CROs by country

CROs in New Zealand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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