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A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)

29. september 2010 opdateret af: GlaxoSmithKline

See Detailed Description

This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A phase IIIB randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive HIV-1 infected subjects.

Undersøgelsestype

Interventionel

Tilmelding

900

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Montgomery, Alabama, Forenede Stater, 36105
        • GSK Investigational Site
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
        • GSK Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85006
        • GSK Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85015
        • GSK Investigational Site
      • Tucson, Arizona, Forenede Stater, 85745
        • GSK Investigational Site
    • California
      • Arleta, California, Forenede Stater, 91331
        • GSK Investigational Site
      • Beverly Hills, California, Forenede Stater, 90211
        • GSK Investigational Site
      • Beverly Hills, California, Forenede Stater, 90210
        • GSK Investigational Site
      • Fresno, California, Forenede Stater, 93720
        • GSK Investigational Site
      • Long Beach, California, Forenede Stater, 90806
        • GSK Investigational Site
      • Long Beach, California, Forenede Stater, 90813
        • GSK Investigational Site
      • Long Beach, California, Forenede Stater, 90801
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90022
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90027
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90048
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90067
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90028
        • GSK Investigational Site
      • Newport Beach, California, Forenede Stater, 92663
        • GSK Investigational Site
      • Oakland, California, Forenede Stater, 94609
        • GSK Investigational Site
      • Oakland, California, Forenede Stater, 94602
        • GSK Investigational Site
      • Palm Springs, California, Forenede Stater, 92262
        • GSK Investigational Site
      • Panorama City, California, Forenede Stater, 91402
        • GSK Investigational Site
      • Paramount, California, Forenede Stater, 90723
        • GSK Investigational Site
      • Riverside, California, Forenede Stater, 92507
        • GSK Investigational Site
      • Salinas, California, Forenede Stater, 93912
        • GSK Investigational Site
      • San Francisco, California, Forenede Stater, 94102
        • GSK Investigational Site
      • San Francisco, California, Forenede Stater, 94114
        • GSK Investigational Site
      • Santa Rosa, California, Forenede Stater, 95404
        • GSK Investigational Site
      • Tarzana, California, Forenede Stater, 91356
        • GSK Investigational Site
      • Tarzana, California, Forenede Stater, 30342
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, Forenede Stater, 80206
        • GSK Investigational Site
      • Denver, Colorado, Forenede Stater, 80204
        • GSK Investigational Site
      • Denver, Colorado, Forenede Stater, 80205
        • GSK Investigational Site
    • Connecticut
      • Glastonbury, Connecticut, Forenede Stater, 06033
        • GSK Investigational Site
      • New Haven, Connecticut, Forenede Stater, 06520
        • GSK Investigational Site
      • Norwalk, Connecticut, Forenede Stater, 06851
        • GSK Investigational Site
      • Stamford, Connecticut, Forenede Stater, 06902
        • GSK Investigational Site
      • Stratford, Connecticut, Forenede Stater, 06614
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • GSK Investigational Site
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33134
        • GSK Investigational Site
      • Coral Springs, Florida, Forenede Stater, 33065
        • GSK Investigational Site
      • Daytona Beach, Florida, Forenede Stater, 32114
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Forenede Stater, 33145
        • GSK Investigational Site
      • Fort Myers, Florida, Forenede Stater, 33901
        • GSK Investigational Site
      • Gainesville, Florida, Forenede Stater, 32601
        • GSK Investigational Site
      • Inmokalee, Florida, Forenede Stater, 34142
        • GSK Investigational Site
      • Key West, Florida, Forenede Stater, 33040
        • GSK Investigational Site
      • Melbourne, Florida, Forenede Stater, 32935
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33176
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33133
        • GSK Investigational Site
      • Miami Beach, Florida, Forenede Stater, 33139
        • GSK Investigational Site
      • North Miami, Florida, Forenede Stater, 33161
        • GSK Investigational Site
      • Orlando, Florida, Forenede Stater, 32804
        • GSK Investigational Site
      • Orlando, Florida, Forenede Stater, 32803
        • GSK Investigational Site
      • Orlando, Florida, Forenede Stater, 32806
        • GSK Investigational Site
      • Pampano, Florida, Forenede Stater, 33062
        • GSK Investigational Site
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • GSK Investigational Site
      • Plantation, Florida, Forenede Stater, 33317
        • GSK Investigational Site
      • Pompano Beach, Florida, Forenede Stater, 33062
        • GSK Investigational Site
      • Port St. Lucie, Florida, Forenede Stater, 34952
        • GSK Investigational Site
      • Sarasota, Florida, Forenede Stater, 34239
        • GSK Investigational Site
      • South Miami, Florida, Forenede Stater, 33143
        • GSK Investigational Site
      • St. Petersburg, Florida, Forenede Stater, 33710
        • GSK Investigational Site
      • Tallahassee, Florida, Forenede Stater, 32308
        • GSK Investigational Site
      • Tamarac, Florida, Forenede Stater, 33321
        • GSK Investigational Site
      • Tampa, Florida, Forenede Stater, 33614
        • GSK Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33401
        • GSK Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33408
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, Forenede Stater, 30309
        • GSK Investigational Site
      • Atlanta, Georgia, Forenede Stater, 30312
        • GSK Investigational Site
      • Atlanta, Georgia, Forenede Stater, 30318
        • GSK Investigational Site
      • Atlanta, Georgia, Forenede Stater, 30329
        • GSK Investigational Site
      • Atlanta, Georgia, Forenede Stater, 30308/30309
        • GSK Investigational Site
      • Austell, Georgia, Forenede Stater, 30106
        • GSK Investigational Site
      • Columbus, Georgia, Forenede Stater, 31906
        • GSK Investigational Site
      • Decatur, Georgia, Forenede Stater, 30033
        • GSK Investigational Site
      • Lawrenceville, Georgia, Forenede Stater, 30045
        • GSK Investigational Site
      • Riverdale, Georgia, Forenede Stater, 30274
        • GSK Investigational Site
    • Idaho
      • Boise, Idaho, Forenede Stater, 83704
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60643
        • GSK Investigational Site
      • Elgin, Illinois, Forenede Stater, 60120
        • GSK Investigational Site
      • Joliet, Illinois, Forenede Stater, 60432
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46204
        • GSK Investigational Site
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50309-1426
        • GSK Investigational Site
    • Kentucky
      • Henderson, Kentucky, Forenede Stater, 42420
        • GSK Investigational Site
      • Louisville, Kentucky, Forenede Stater, 40202
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70816
        • GSK Investigational Site
      • New Orleans, Louisiana, Forenede Stater, 70115
        • GSK Investigational Site
      • New Orleans, Louisiana, Forenede Stater, 70117
        • GSK Investigational Site
      • New Orleans, Louisiana, Forenede Stater, 70121
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • GSK Investigational Site
      • Baltimore, Maryland, Forenede Stater, 21209
        • GSK Investigational Site
      • Baltimore, Maryland, Forenede Stater, 21218
        • GSK Investigational Site
      • Baltimore, Maryland, Forenede Stater, 21229-5299
        • GSK Investigational Site
      • Bethesda, Maryland, Forenede Stater, 20816
        • GSK Investigational Site
      • Clinton, Maryland, Forenede Stater, 20735
        • GSK Investigational Site
      • Silver Spring, Maryland, Forenede Stater, 20910
        • GSK Investigational Site
    • Massachusetts
      • Lowell, Massachusetts, Forenede Stater, 01854
        • GSK Investigational Site
      • Springfield, Massachusetts, Forenede Stater, 01107
        • GSK Investigational Site
    • Michigan
      • Berkeley, Michigan, Forenede Stater, 48072
        • GSK Investigational Site
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • GSK Investigational Site
      • Lansing, Michigan, Forenede Stater, 48910
        • GSK Investigational Site
      • St. Louis, Michigan, Forenede Stater, 63117
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63017
        • GSK Investigational Site
      • Columbia, Missouri, Forenede Stater, 65212
        • GSK Investigational Site
      • Kansas City, Missouri, Forenede Stater, 64132
        • GSK Investigational Site
      • Kansas City, Missouri, Forenede Stater, 64112
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89015
        • GSK Investigational Site
      • Las Vegas, Nevada, Forenede Stater, 79102
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • GSK Investigational Site
    • New Jersey
      • East Orange, New Jersey, Forenede Stater, 07017
        • GSK Investigational Site
      • Englewood, New Jersey, Forenede Stater, 07631
        • GSK Investigational Site
      • Galloway, New Jersey, Forenede Stater, 08205
        • GSK Investigational Site
      • Hoboken, New Jersey, Forenede Stater, 07030
        • GSK Investigational Site
      • Jersey City, New Jersey, Forenede Stater, 07304
        • GSK Investigational Site
      • Jersey City, New Jersey, Forenede Stater, 07306
        • GSK Investigational Site
      • Newark, New Jersey, Forenede Stater, 07102
        • GSK Investigational Site
      • Newark, New Jersey, Forenede Stater, 07112
        • GSK Investigational Site
      • Newark, New Jersey, Forenede Stater, 07101-1709
        • GSK Investigational Site
      • Somers Point, New Jersey, Forenede Stater, 08244
        • GSK Investigational Site
      • Westfield, New Jersey, Forenede Stater, 07090
        • GSK Investigational Site
    • New Mexico
      • Santa Fe, New Mexico, Forenede Stater, 87505
        • GSK Investigational Site
    • New York
      • Albany, New York, Forenede Stater, 12208
        • GSK Investigational Site
      • Bronx, New York, Forenede Stater, 10457
        • GSK Investigational Site
      • Brooklyn, New York, Forenede Stater, 11201
        • GSK Investigational Site
      • Brooklyn, New York, Forenede Stater, 11215
        • GSK Investigational Site
      • Brooklyn, New York, Forenede Stater, 11212
        • GSK Investigational Site
      • Brooklyn, New York, Forenede Stater, 11220
        • GSK Investigational Site
      • Brooklyn, New York, Forenede Stater, 11237
        • GSK Investigational Site
      • Great Neck, New York, Forenede Stater, 10020
        • GSK Investigational Site
      • Manhasset, New York, Forenede Stater, 11030
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10022
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10025
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10016
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10003
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10011
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10019
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10010
        • GSK Investigational Site
      • Staten Island, New York, Forenede Stater, 10304
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28211
        • GSK Investigational Site
      • Huntersville, North Carolina, Forenede Stater, 28078
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44109
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97209
        • GSK Investigational Site
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19146
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19131
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19143
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19103
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19121
        • GSK Investigational Site
      • Reading, Pennsylvania, Forenede Stater, 19601
        • GSK Investigational Site
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • GSK Investigational Site
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • GSK Investigational Site
    • Tennessee
      • Johnson City, Tennessee, Forenede Stater, 37614
        • GSK Investigational Site
      • Memphis, Tennessee, Forenede Stater, 38120
        • GSK Investigational Site
      • Memphis, Tennessee, Forenede Stater, 38104
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, Forenede Stater, 76015
        • GSK Investigational Site
      • Austin, Texas, Forenede Stater, 78705
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75235
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75219
        • GSK Investigational Site
      • El Paso, Texas, Forenede Stater, 79905
        • GSK Investigational Site
      • Galveston, Texas, Forenede Stater, 77555-0188
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77027
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77004
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77098
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77009
        • GSK Investigational Site
      • Longview, Texas, Forenede Stater, 75604
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • GSK Investigational Site
      • Tyler, Texas, Forenede Stater, 75708
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • GSK Investigational Site
    • Virginia
      • Annandale, Virginia, Forenede Stater, 22003
        • GSK Investigational Site
      • Fairfax, Virginia, Forenede Stater, 22030
        • GSK Investigational Site
      • Richmond, Virginia, Forenede Stater, 23224
        • GSK Investigational Site
    • Washington
      • Spokane, Washington, Forenede Stater, 99204
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53212
        • GSK Investigational Site

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Have HIV-1 infection.
  • Had not received any prior HIV treatment for more than 14 days.
  • At least 1000 copies of HIV-1 RNA.
  • Willing to provide signed informed consent.

Exclusion Criteria:

  • Enrolled in other investigational drug studies.
  • Female subjects who are pregnant or breastfeeding.
  • History of allergy or hypersensitivity to abacavir or lamivudine.
  • Certain medical conditions that would make subjects ineligible.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
The occurrence of treatment-limiting adverse events after starting study drugs.

Sekundære resultatmål

Resultatmål
occurrence of abacavir HSR
completion of educational training
subject satisfaction with treatment
adherence to study medications
change in HIV-1 RNA from BL
change in CD4 measure from BL.

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

Efterforskere

  • Studieleder: GSK Clinical Trials, PharmD, GlaxoSmithKline

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. juli 2004

Primær færdiggørelse (Faktiske)

1. oktober 2005

Studieafslutning (Faktiske)

1. oktober 2005

Datoer for studieregistrering

Først indsendt

16. oktober 2004

Først indsendt, der opfyldte QC-kriterier

16. oktober 2004

Først opslået (Skøn)

18. oktober 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. september 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2010

Sidst verificeret

1. september 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 101822

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 .

Kliniske forsøg med HIV-infektion

Kliniske forsøg med Abacavir/Lamivudin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cyprus

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner