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A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

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

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies

This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

351

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

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

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient must be HIV positive with HIV RNA values that are within ranges required by the study
  • Patient must have documented failure of certain antiretroviral therapy
  • Patient must be on the same antiretroviral therapy for at least the past two months

Exclusion Criteria:

  • Patient less than 16 years old
  • Additional study criteria will be discussed and identified by the study doctor

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
Placebo komparator: 2
Placebo
Medicin: Comparator: placebo
Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.
Eksperimentel: 1
raltegravir potassium
Medicin: raltegravir potassium
Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
Andre navne:
  • ISENTRESS™

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
Tidsramme: 16 Weeks
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16
16 Weeks
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
Tidsramme: 48 Weeks
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48
48 Weeks
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Tidsramme: 156 Weeks
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156
156 Weeks
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Tidsramme: 240 Weeks
Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240
240 Weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
Tidsramme: 16 Weeks
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16
16 Weeks
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
Tidsramme: 48 Weeks
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48
48 Weeks
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
Tidsramme: Baseline and Week 48
Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
Baseline and Week 48
Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
Tidsramme: Baseline and Week 156
Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)
Baseline and Week 156
Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
Tidsramme: Baseline and Week 240
Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)
Baseline and Week 240
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Tidsramme: 156 Weeks
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156
156 Weeks
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Tidsramme: 240 Weeks
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240
240 Weeks
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
Tidsramme: 156 Weeks
For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free).
156 Weeks
Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16
Tidsramme: Baseline and Week 16
Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)
Baseline and Week 16
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
Tidsramme: Baseline and Week 16
Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)
Baseline and Week 16
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Tidsramme: Baseline and Week 48
Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)
Baseline and Week 48
Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)
Tidsramme: Baseline and Week 156
Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)
Baseline and Week 156
Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
Tidsramme: Baseline and Week 240
Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)
Baseline and Week 240

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. februar 2006

Primær færdiggørelse (Faktiske)

1. oktober 2007

Studieafslutning (Faktiske)

1. maj 2011

Datoer for studieregistrering

Først indsendt

15. februar 2006

Først indsendt, der opfyldte QC-kriterier

15. februar 2006

Først opslået (Skøn)

17. februar 2006

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

  • 0518-019
  • 2005_097

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 .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med raltegravir potassium

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Trinidad & Tobago

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner