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A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

23. maj 2017 opdateret af: GlaxoSmithKline

A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (Abacavir 300mg, Lamivudine 150mg, and Zidovudine 300mg) BID vs Combivir (Lamivudine 150mg and Zidovudine 300mg) BID Plus Atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects Over 48 Weeks

The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (abacavir 300mg, lamivudine 150mg, and zidovudine 300mg) BID vs Combivir (lamivudine 150mg and zidovudine 300mg) BID plus atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects over 48 Weeks

Undersøgelsestype

Interventionel

Fase

Fase 4

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- California
  - Bakersfield, California, Forenede Stater, 93301
    - GSK Investigational Site
  - Los Angeles, California, Forenede Stater, 90069
    - GSK Investigational Site
  - Oakland, California, Forenede Stater, 94609
    - GSK Investigational Site
  - San Francisco, California, Forenede Stater, 94121
    - GSK Investigational Site
- Colorado
  - Fort Collins, Colorado, Forenede Stater, 80528
    - GSK Investigational Site
- District of Columbia
  - Washington, D.C., District of Columbia, Forenede Stater, 20007
    - GSK Investigational Site
- Florida
  - Fort Lauderdale, Florida, Forenede Stater, 33306
    - 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
  - Miami, Florida, Forenede Stater, 33136
    - GSK Investigational Site
  - Miami Beach, Florida, Forenede Stater, 33140
    - GSK Investigational Site
  - Orlando, Florida, Forenede Stater, 32804
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30339
    - GSK Investigational Site
  - Decatur, Georgia, Forenede Stater, 30033
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, Forenede Stater, 60637
    - GSK Investigational Site
- Kansas
  - Wichita, Kansas, Forenede Stater, 67214
    - GSK Investigational Site
- Kentucky
  - Louisville, Kentucky, Forenede Stater, 40202
    - GSK Investigational Site
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70115
    - GSK Investigational Site
  - New Orleans, Louisiana, Forenede Stater, 70112
    - GSK Investigational Site
  - New Orleans, Louisiana, Forenede Stater, 70127-0800
    - GSK Investigational Site
- Missouri
  - Saint Louis, Missouri, Forenede Stater, 63139
    - GSK Investigational Site
- New Jersey
  - East Orange, New Jersey, Forenede Stater, 7017
    - GSK Investigational Site
  - Hillsborough, New Jersey, Forenede Stater, 08876
    - GSK Investigational Site
  - Newark, New Jersey, Forenede Stater, 7102
    - GSK Investigational Site
  - Voorhees, New Jersey, Forenede Stater, 08043
    - GSK Investigational Site
- New York
  - Mount Vernon, New York, Forenede Stater, 10550
    - GSK Investigational Site
  - Valhalla, New York, Forenede Stater, 10595
    - GSK Investigational Site
- North Carolina
  - Charlotte, North Carolina, Forenede Stater, 28209
    - GSK Investigational Site
  - Greenville, North Carolina, Forenede Stater, 27858-4354
    - GSK Investigational Site
- Ohio
  - Akron, Ohio, Forenede Stater, 44304
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, Forenede Stater, 97219
    - GSK Investigational Site
- Pennsylvania
  - Allentown, Pennsylvania, Forenede Stater, 18102
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, Forenede Stater, 19140
    - GSK Investigational Site
  - West Reading, Pennsylvania, Forenede Stater, 19611
    - GSK Investigational Site
- South Carolina
  - Columbia, South Carolina, Forenede Stater, 29203
    - GSK Investigational Site
  - Greenville, South Carolina, Forenede Stater, 29605
    - GSK Investigational Site
- Texas
  - Austin, Texas, Forenede Stater, 78705
    - GSK Investigational Site
  - Dallas, Texas, Forenede Stater, 75246
    - GSK Investigational Site
  - Dallas, Texas, Forenede Stater, 75208
    - GSK Investigational Site
  - Harlingen, Texas, Forenede Stater, 78550
    - GSK Investigational Site
  - Houston, Texas, Forenede Stater, 77027
    - GSK Investigational Site
- Virginia
  - Hampton, Virginia, Forenede Stater, 23666
    - GSK Investigational Site
Mexico
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44340
    - GSK Investigational Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - 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:

Adults with documented HIV-1 infection.
Past use of HIV drugs must have been less than 15 days.
Plasma HIV-1 RNA between 500 and 20,000 copies/mL.
CD4+ cell count greater than 100 cells/mm3.
Willing/able to provide written informed consent.

Exclusion criteria:

Have AIDS at screening.
Pregnant or breastfeeding.
Underlying medical conditions considered to be significant for this protocol.
Participating in other investigational drug trials.
In the opinion of the investigator, would be unable to complete 48 weeks of dosing.

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. Tidsramme: 48 Weeks	48 Weeks

Sekundære resultatmål

Resultatmål	Tidsramme
% patients with plasma HIV-1 RNA <50 and <400 copies/mL at weeks 24 & 48; Change from BL in plasma HIV-1 RNA and CD4+ measures; AEs; Time to virologic failure Tidsramme: 48 Weeks	48 Weeks

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

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.

Generelle publikationer

Kumar PN, Salvato P, LaMarca A, DeJesus E, Patel P, McClernon D, Florance A, Shaefer MS. A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study). AIDS Res Ther. 2009 Apr 9;6:3. doi: 10.1186/1742-6405-6-3.

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 (Faktiske)

26. april 2004

Primær færdiggørelse (Faktiske)

1. marts 2006

Studieafslutning (Faktiske)

1. marts 2006

Datoer for studieregistrering

Først indsendt

6. maj 2004

Først indsendt, der opfyldte QC-kriterier

7. maj 2004

Først opslået (Skøn)

10. maj 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

100327

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 .