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Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients (SPARTAN)

2 febbraio 2015 aggiornato da: Bristol-Myers Squibb

An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.

The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Allocation: Randomized nonstratified

Intervention model: Parallel versus comparator

Tipo di studio

Interventistico

Iscrizione (Effettivo)

132

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Lyons Cedex 04, Francia, 69317
        • Local Institution
      • Orleans Cedex 2, Francia, 45067
        • Local Institution
      • Paris, Francia, 75020
        • Local Institution
      • Paris Cedex 14, Francia, 75679
        • Local Institution
      • Strasbourg Cedex, Francia, 67091
        • Local Institution
    • Cedex 12
      • Paris, Cedex 12, Francia, 75551
        • Local Institution
  • Germania
      • Bochum, Germania, 44791
        • Local Institution
      • Frankfurt, Germania, 60590
        • Local Institution
      • Frankfurt Am Main, Germania, 60311
        • Local Institution
      • Hamburg, Germania, 20246
        • Local Institution
      • Munich, Germania, 80336
        • Local Institution
  • Italia
      • Genova, Italia, 16128
        • Local Institution
      • Genova, Italia, 16132
        • Local Institution
      • Milano, Italia, 20127
        • Local Institution
      • Milano, Italia, 20142
        • Local Institution
      • Roma, Italia, 00149
        • Local Institution
  • Polonia
      • Warszawa, Polonia, 01-201
        • Local Institution
      • Wroclaw, Polonia, 50-136
        • Local Institution
  • Regno Unito
      • Brighton, Regno Unito, BN2 1ES
        • Local Institution
      • London, Regno Unito, E9 6SR
        • Local Institution
      • London, Regno Unito, NW3 2QG
        • Local Institution
      • Sheffield, Regno Unito, S10 2RX
        • Local Institution
    • Greater London
      • London, Greater London, Regno Unito, SW10 9EL
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, Regno Unito, M8 5RB
        • Local Institution
  • Spagna
      • Alicante, Spagna, 03010
        • Local Institution
      • Barcelona, Spagna, 08036
        • Local Institution
      • Madrid, Spagna, 28006
        • Local Institution
      • Madrid, Spagna, 28007
        • Local Institution
      • Madrid, Spagna, 28046
        • Local Institution
      • Madrid, Spagna, 28805
        • Local Institution
  • Stati Uniti
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72207
        • Health For Life Clinic Pllc
    • California
      • Palm Springs, California, Stati Uniti, 92264
        • Eisenhower Medical Center
      • San Francisco, California, Stati Uniti, 94109
        • Metropolis Medical Pc
    • Florida
      • Daytona Beach, Florida, Stati Uniti, 32117
        • Consultive Medicine
      • Orlando, Florida, Stati Uniti, 32805
        • Orange County Health Dept.
      • West Palm Beach, Florida, Stati Uniti, 33401
        • Triple O Medical Services, P.A.
    • Massachusetts
      • Springfield, Massachusetts, Stati Uniti, 01105
        • The Research Institute
    • New York
      • Rochester, New York, Stati Uniti, 14607
        • Aids Care

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Key Inclusion Criteria

  • Current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus any third agent for at least 3 months immediately prior to screening
  • Virologic suppression (HIV-1 RNA <50 c/mL) for at least 3 months immediately prior to screening
  • Virologic suppression (HIV-1 RNA <40 c/mL) using the Abbott m2000rt® polymerase chain reaction assay during screening period
  • Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs plus any third agent

Key Exclusion Criteria

  • History of switch in highly active antiretroviral therapy due to virologic failure
  • History of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine)
  • History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study
  • Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir
  • Switch of any component of HIV antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
Droga: Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
Altri nomi:
  • Reyataz
Droga: Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
Altri nomi:
  • Norvir
Droga: Raltegravir
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Altri nomi:
  • Isentress
Altro: Atazanavir/Ritonavir + Tenofovir/Emtricitabine

Reference

Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
Droga: Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
Altri nomi:
  • Reyataz
Droga: Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
Altri nomi:
  • Norvir
Droga: Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, Once daily, 48 weeks
Altri nomi:
  • Truvada

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
Lasso di tempo: From Day 1 to Week 24
HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.
From Day 1 to Week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Lasso di tempo: From Day 1 to Week 48
Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.
From Day 1 to Week 48
Number of Participants With Virologic Rebound at Weeks 24 and 48
Lasso di tempo: Day 1 to Weeks 28 and 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
Day 1 to Weeks 28 and 48
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
Lasso di tempo: Day 1 to Week 24
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Day 1 to Week 24
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
Lasso di tempo: Day 1 to Week 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Day 1 to Week 48
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
Lasso di tempo: Day 1 to Week 48
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Day 1 to Week 48
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Lasso di tempo: From Baseline to Week 48
LD=low-density lipoprotein; HDL=high-density lipoprotein.
From Baseline to Week 48

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Investigatori

  • Direttore dello studio: Bristol-Mayers Squibb, Bristol-Mayers Squibb

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2011

Completamento primario (Effettivo)

1 settembre 2013

Completamento dello studio (Effettivo)

1 febbraio 2014

Date di iscrizione allo studio

Primo inviato

7 aprile 2011

Primo inviato che soddisfa i criteri di controllo qualità

8 aprile 2011

Primo Inserito (Stima)

11 aprile 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 febbraio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 febbraio 2015

Ultimo verificato

1 febbraio 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AI424-402
  • 2009-017032-41 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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