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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering

900

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

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

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:

  • 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

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
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.

Samarbeidspartnere og etterforskere

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

Sponsor

GlaxoSmithKline

Etterforskere

  • Studieleder: GSK Clinical Trials, PharmD, GlaxoSmithKline

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 2004

Primær fullføring (Faktiske)

1. oktober 2005

Studiet fullført (Faktiske)

1. oktober 2005

Datoer for studieregistrering

Først innsendt

16. oktober 2004

Først innsendt som oppfylte QC-kriteriene

16. oktober 2004

Først lagt ut (Anslag)

18. oktober 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. september 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2010

Sist bekreftet

1. september 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 101822

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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