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Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa (THILAO)

16. februar 2017 opdateret af: ANRS, Emerging Infectious Diseases

Systematic "Adherence Intervention" Phase Before Switching to 3rd-line ART in Patients With 2nd-line ART Virologic Failure in Sub-Saharan Africa : a Phase 2b Non-randomized Study.

Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa.

HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be recruited and followed in two phases:

  • First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers;

  • Second, a 48-week phase, during which:

    • Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement;
    • Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART.

Genotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64 weeks.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Main objective

To estimate, in sub-Saharan African HIV-1 infected adults who failed a NNRTI-base first-line ART and then a PI-based second-line ART:

  1. The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase;
  2. In patients who successfully resuppress at 12 weeks: The percentage of patients still with continuing succesfull virologic supression on 2nd-line ART at 64 weeks (and factors associated to success) ;
  3. In patients with persistent failure at 12 weeks : The efficacy (and associated factors) at 64 weeks of a darunavir/r + raltegravir-based 3rd-line regimen.

Number of participants : 200

Main outcome :

  • At 12 weeks : Proportion of patients with a plasma HIV-1 RNA <400 copies/ml and/or with a decrease in plasma HIV-1 RNA >2 log10 copies/ml between inclusion and 12 weeks;
  • At 64 weeks : proportion of patients with a plasma HIV-1 RNA <50 copies/ml.

Inclusion criteria:

  • Age >18 years
  • Documented HIV-1 infection.
  • History of failing a NNRTI-based 1st-line ART
  • Current PI-based 2nd-line ART >6 months
  • Plasma HIV-1 RNA >1000 copies/ml
  • Signed informed consent

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

201

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Burkina Faso
      • Bobo-Dioulasso, Burkina Faso
        • CHU Souro Sanou
      • Ouagadougou, Burkina Faso
        • CHU Yalgado Ouedraogo
  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
        • Centre de Prise en Charge et de Formation (CePReF), Association ACONDA
      • Abidjan, Côte D'Ivoire
        • Service des Maladies Infectieuses et Tropicales (SMIT)
  • Mali
      • Bamako, Mali
        • Centre d'Ecoute, de Soins, d'Animation et de Conseils (CESAC)
      • Bamako, Mali
        • CHU point G
  • Senegal
      • Dakar, Senegal
        • CHU Fann

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:

  • Age >18 years
  • Documented HIV-1 infection
  • History of failing a NNRTI-based 1st-line ART
  • Current PI-based 2nd-line ART >6 months
  • Plasma HIV-1 RNA >1000 copies/ml
  • Signed informed consent

Exclusion Criteria:

  • HIV-2 infection
  • Any Severe clinical event under exploration
  • History of treatment including darunavir or raltegravir.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Adherence reinforcement before switch to 3rd-line ART
Adfærdsmæssigt: adherence reinforcement
Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.
Medicin: Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)

Second-line ART regimen : ongoing regimen at the time of inclusion will be continued.

Third-line ART regimen : Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Virologic efficacy of the adherence reinforcement intervention
Tidsramme: Week 12
Proportion of patients with plasma viral load <400 copies/ml at Week 12 and/or with a decrease in plasma viral load >2 log10 copies/ml between inclusion and Week 12
Week 12
Persistent virologic efficacy of the adherence reinforcement intervention
Tidsramme: Week 64
Proportion of patients with plasma viral load <50 copies/ ml at Week 64 among those who stayed on 2nd-line ART at Week 16
Week 64
Virologic efficacy of 3rd-line ART
Tidsramme: Week 64
Proportion of patients with HIV-1 plasma viral load <50 copies/ml at Week 64 among those with persistent failure at Week 12 who switched to 3rd-line ART
Week 64

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immunological efficacy of the adherence reinforcement intervention
Tidsramme: Week 12
CD4 count evolution between inclusion and Week 12
Week 12
Immunological efficacy of 3rd-line ART
Tidsramme: Week 64
CD4 count evolution between Week12 and Week 64 among patients who switched to 3rd-line ART at Week 16
Week 64
Tolerance of 3rd-line ART drugs
Tidsramme: Week 64
Incidence of grade 3-4 adverse events (ANRS grading table) in patients on 3rd-line ART
Week 64
Adherence to 3rd-line ART
Tidsramme: Week 64
3rd-line Medication Possession Ratio between Week 16 and Week 64
Week 64
Resistance to 1st and 2nd-line antiretroviral drugs
Tidsramme: Week 12
Resistance mutations to antiretroviral drugs among patients with virological failure at Week 12
Week 12
Resistance to 1st, 2nd and 3rd-line antiretroviral drugs
Tidsramme: Week 64
Resistance mutations to antiretroviral drugs among patients with virological failure at Week 64
Week 64
Plasma antiretroviral drugs concentration
Tidsramme: Week 12
Plasma antiretroviral drugs concentration at Week 12
Week 12
Plasma antiretroviral drugs concentration
Tidsramme: Week 64
Plasma antiretroviral drugs concentration at Week 64
Week 64

Samarbejdspartnere og efterforskere

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

Sponsor

ANRS, Emerging Infectious Diseases

Efterforskere

  • Ledende efterforsker: Serge P. Eholié, MD, MSc, Pr, Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire
  • Ledende efterforsker: Roland Landman, MD, Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France
  • Studiestol: Pierre-Marie Girard, MD, PhD, Infectious Diseases Department, University Hospital Saint Antoine, Paris, France
  • Studieleder: Xavier Anglaret, MD, PhD, Inserm 897, University of Bordeaux, France

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.

Hjælpsomme links

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. marts 2013

Primær færdiggørelse (Faktiske)

1. august 2016

Studieafslutning (Forventet)

1. maj 2017

Datoer for studieregistrering

Først indsendt

30. december 2013

Først indsendt, der opfyldte QC-kriterier

31. december 2013

Først opslået (Skøn)

1. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ANRS 12269 THILAO

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-infektion

Kliniske forsøg med adherence reinforcement

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Portugal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner