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Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only

30. oktober 2008 opdateret af: Hospital de Calella

Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors

The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

RTNI (reverse transcriptase nucleoside inhibitors) are a regular part of most antiretroviral combinations. The presence of a smaller or greater degree of cross resistance among all RTNI is increasingly better described and acknowledged, whereby the number of salvage regimens that may be built following the appearance of this resistance to these drugs is by no means unlimited.

This proactive treatment change in patients on RTNI-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate. This therapeutic approach has demonstrated its effectiveness in clinical practice, albeit not in this scenario.

If we wait until the viral load is detectable there is sufficient evidence that resistance to RTNI will appear and that this resistance will compromise future salvage options.

To intensify with this proactive approach these combinations based on N/NNRTI (nucleotide analog), the NNRTI are an optimal alternative.There is vast experience with NVP in simplification/maintenance trials. In direct comparative simplification studies in patients with virological response, the response rates with NVP or EFV have shown no differences. With a relative risk (RR) of virological failure of 0.54 with regard to the continuation of PI (protease inhibitors), NVP is one of the best simplification treatment options in HIV-1-infected patients.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Vall d'hebrón
      • Barcelona, Spanien, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spanien, 08009
        • Centre Penitenciari Brians
      • Barcelona, Spanien, 08025
        • Hopsital de Sant Pau
      • Barcelona, Spanien, 08370
        • Hospital Sant Jaume de Calella
      • Barcelona, Spanien
        • Centre Penitenciari Homes
      • Madrid, Spanien, 28040
        • Hospital Clínico San Carlos de Madrid
      • Tortosa, Spanien, 43500
        • Hospital de Tortosa
      • Valencia, Spanien, 46009
        • Hospital La Fe de Valencia
      • Zaragoza, Spanien, 50009
        • Hospital Miguel Servet
    • Barcelona
      • Badalona, Barcelona, Spanien, 08916
        • Hospital.Universitari Germans Trias i Pujol
      • Granollers, Barcelona, Spanien, 08400
        • Hospital General de Granollers
      • Granollers, Barcelona, Spanien, 08430
        • Centre Penitenciari Quatre Camins
      • Hospitalet de Llobregat, Barcelona, Spanien, 08907
        • Hospital de Bellvitge
      • Terrassa, Barcelona, Spanien, 08221
        • Mútua de Terrassa
    • Canarias
      • Tenerife, Canarias, Spanien, 38010
        • Hospital La Candelaria
    • Tarragona
      • Reus, Tarragona, Spanien, 43201
        • Hospital Universitari Sant Joan de Reus

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:

  • Patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression.
  • Age >= 18 years.
  • Confirmed diagnosis of HIV-1 infection.
  • Viral load < 50 copies/ml over the previous six months, including at least two consecutive determinations.
  • Value of ALT transaminase £ 2.5 times the normal value of the laboratory of each centre.
  • Acceptance and signature of the informed consent form.

Exclusion Criteria:

  • Pregnant women or those who intend to become pregnant in the study period.
  • Having had an active infection in the previous month.
  • Previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine).
  • Simultaneous treatment with methadone.
  • Patients with serious hepatic dysfunction

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)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 1
Follow with same ARV treatment
Eksperimentel: 2
Switch one of ARV drugs to Nevirapine
Medicin: Nevirapine
Switch one of ARV drugs to Nevirapine
Andre navne:
  • Switch one of ARV drugs to Nevirapine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients with plasma viral load below 50 copies/mL .
Tidsramme: after 48 weeks of follow-up
after 48 weeks of follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both).
Tidsramme: During the 48 weeks of follow-up.
During the 48 weeks of follow-up.
Evolution of the CD4 lymphocyte count at 48 weeks.
Tidsramme: during 48 weeks of follow-up
during 48 weeks of follow-up
Pattern of mutations associated with resistance in patients presenting virological failure.
Tidsramme: When there is a virological failure
When there is a virological failure
Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment.
Tidsramme: during the 48 weeks of follow-up
during the 48 weeks of follow-up
Incidence of AIDS-defining events (CDC C events, 1993).
Tidsramme: during the 48 weeks of follow-up
during the 48 weeks of follow-up
Mortality by any cause.
Tidsramme: during the 48 weeks of follow-up
during the 48 weeks of follow-up

Samarbejdspartnere og efterforskere

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

Sponsor

Hospital de Calella

Efterforskere

  • Ledende efterforsker: Josep Mª Llibre, MD,PhD, Hospital Sant Jaume de Calella

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. august 2004

Primær færdiggørelse (Faktiske)

1. juli 2006

Studieafslutning (Faktiske)

1. juli 2006

Datoer for studieregistrering

Først indsendt

19. december 2006

Først indsendt, der opfyldte QC-kriterier

21. december 2006

Først opslået (Skøn)

22. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. oktober 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2008

Sidst verificeret

1. oktober 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TRIMUNE

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