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

2 februari 2015 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Allocation: Randomized nonstratified

Intervention model: Parallel versus comparator

Studietyp

Interventionell

Inskrivning (Faktisk)

132

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Förenta staterna
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72207
        • Health For Life Clinic Pllc
    • California
      • Palm Springs, California, Förenta staterna, 92264
        • Eisenhower Medical Center
      • San Francisco, California, Förenta staterna, 94109
        • Metropolis Medical Pc
    • Florida
      • Daytona Beach, Florida, Förenta staterna, 32117
        • Consultive Medicine
      • Orlando, Florida, Förenta staterna, 32805
        • Orange County Health Dept.
      • West Palm Beach, Florida, Förenta staterna, 33401
        • Triple O Medical Services, P.A.
    • Massachusetts
      • Springfield, Massachusetts, Förenta staterna, 01105
        • The Research Institute
    • New York
      • Rochester, New York, Förenta staterna, 14607
        • Aids Care
  • Italien
      • Genova, Italien, 16128
        • Local Institution
      • Genova, Italien, 16132
        • Local Institution
      • Milano, Italien, 20127
        • Local Institution
      • Milano, Italien, 20142
        • Local Institution
      • Roma, Italien, 00149
        • Local Institution
  • Polen
      • Warszawa, Polen, 01-201
        • Local Institution
      • Wroclaw, Polen, 50-136
        • Local Institution
  • Spanien
      • Alicante, Spanien, 03010
        • Local Institution
      • Barcelona, Spanien, 08036
        • Local Institution
      • Madrid, Spanien, 28006
        • Local Institution
      • Madrid, Spanien, 28007
        • Local Institution
      • Madrid, Spanien, 28046
        • Local Institution
      • Madrid, Spanien, 28805
        • Local Institution
  • Storbritannien
      • Brighton, Storbritannien, BN2 1ES
        • Local Institution
      • London, Storbritannien, E9 6SR
        • Local Institution
      • London, Storbritannien, NW3 2QG
        • Local Institution
      • Sheffield, Storbritannien, S10 2RX
        • Local Institution
    • Greater London
      • London, Greater London, Storbritannien, SW10 9EL
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, Storbritannien, 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
Läkemedel: Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
Andra namn:
  • Reyataz
Läkemedel: Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
Andra namn:
  • Norvir
Läkemedel: Raltegravir
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Andra namn:
  • Isentress
Övrig: Atazanavir/Ritonavir + Tenofovir/Emtricitabine

Reference

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bristol-Myers Squibb

Utredare

  • Studierektor: Bristol-Mayers Squibb, Bristol-Mayers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2011

Primärt slutförande (Faktisk)

1 september 2013

Avslutad studie (Faktisk)

1 februari 2014

Studieregistreringsdatum

Först inskickad

7 april 2011

Först inskickad som uppfyllde QC-kriterierna

8 april 2011

Första postat (Uppskatta)

11 april 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

19 februari 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 februari 2015

Senast verifierad

1 februari 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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