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

2. februar 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Allocation: Randomized nonstratified

Intervention model: Parallel versus comparator

Studietype

Intervensjonell

Registrering (Faktiske)

132

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
Legemiddel: Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
Andre navn:
  • Reyataz
Legemiddel: Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
Andre navn:
  • Norvir
Legemiddel: Raltegravir
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Andre navn:
  • Isentress
Annen: Atazanavir/Ritonavir + Tenofovir/Emtricitabine

Reference

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From Baseline to Week 48
LD=low-density lipoprotein; HDL=high-density lipoprotein.
From Baseline to Week 48

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Etterforskere

  • Studieleder: Bristol-Mayers Squibb, Bristol-Mayers Squibb

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2011

Primær fullføring (Faktiske)

1. september 2013

Studiet fullført (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først innsendt

7. april 2011

Først innsendt som oppfylte QC-kriteriene

8. april 2011

Først lagt ut (Anslag)

11. april 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. februar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. februar 2015

Sist bekreftet

1. februar 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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