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A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)

14. februar 2017 opdateret af: Merck Sharp & Dohme LLC

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients

A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve human immunodeficiency virus (HIV)-infected patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Following the 96-week double-blind study period (MK0518-071)(NCT00745823), subjects may enroll in an extension study (MK0518-071-10)(NCT00745823). From weeks 96 to 120, subjects' treatment assignments will remain as in the base study.

From week 120 to 240, all subjects will receive open-label raltegravir (800 mg, once daily) in combination with TRUVADA™.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

775

Fase

  • Fase 3

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:

  • Patient is male or female 18 years of age or older
  • Patient is HIV positive
  • Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days total of any ART

Extension Study:

  • The planned extension study did not take place as the study was terminated after the Week 48 analysis.

Exclusion Criteria:

  • Patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
  • Patient has documented resistance to tenofovir or emtricitabine
  • Patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent
  • Patient is pregnant or breastfeeding, or expecting to conceive

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Raltegravir 400 mg b.i.d.
Medicin: Comparator: Raltegravir 400 mg b.i.d.
Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.)
Andre navne:
  • ISENTRESS™
Medicin: TRUVADA™
One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Eksperimentel: Raltegravir 800 mg q.d.
Medicin: TRUVADA™
One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Medicin: Experimental: Raltegravir 800 mg q.d.
Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.
Andre navne:
  • ISENTRESS™

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks
Tidsramme: Week 48
Week 48
Number of Participants With One or More Adverse Events at 48 Weeks
Tidsramme: Week 48
Week 48
Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks
Tidsramme: Week 48
Week 48

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks
Tidsramme: 48 weeks
48 weeks
Mean Change From Baseline to Week 48 in CD4 Cell Count
Tidsramme: Baseline and Week 48
Baseline and Week 48
Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks
Tidsramme: Week 96
As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Week 96
Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks
Tidsramme: Week 96
As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Week 96
Mean Change From Baseline to Week 96 in CD4 Cell Count
Tidsramme: Baseline and Week 96
As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Baseline and Week 96
Number of Participants With One or More Adverse Events at 96 Weeks
Tidsramme: Week 96
As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Week 96
Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks
Tidsramme: Week 96
As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Week 96

Samarbejdspartnere og efterforskere

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

Sponsor

Merck Sharp & Dohme LLC

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

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. september 2008

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. maj 2011

Datoer for studieregistrering

Først indsendt

2. september 2008

Først indsendt, der opfyldte QC-kriterier

2. september 2008

Først opslået (Skøn)

3. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0518-071
  • 2008_543 (Anden identifikator: Merck Registration Number)
  • CTRI/2009/091/000145 (Registry Identifier: CTRI)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

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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