- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01332227
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients (SPARTAN)
2. februar 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Allocation: Randomized nonstratified
Intervention model: Parallel versus comparator
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
132
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brighton, Det Forenede Kongerige, BN2 1ES
- Local Institution
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London, Det Forenede Kongerige, E9 6SR
- Local Institution
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London, Det Forenede Kongerige, NW3 2QG
- Local Institution
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Sheffield, Det Forenede Kongerige, S10 2RX
- Local Institution
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Greater London
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London, Greater London, Det Forenede Kongerige, SW10 9EL
- Local Institution
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Greater Manchester
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Manchester, Greater Manchester, Det Forenede Kongerige, M8 5RB
- Local Institution
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72207
- Health For Life Clinic Pllc
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California
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Palm Springs, California, Forenede Stater, 92264
- Eisenhower Medical Center
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San Francisco, California, Forenede Stater, 94109
- Metropolis Medical Pc
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Florida
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Daytona Beach, Florida, Forenede Stater, 32117
- Consultive Medicine
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Orlando, Florida, Forenede Stater, 32805
- Orange County Health Dept.
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West Palm Beach, Florida, Forenede Stater, 33401
- Triple O Medical Services, P.A.
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Massachusetts
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Springfield, Massachusetts, Forenede Stater, 01105
- The Research Institute
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New York
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Rochester, New York, Forenede Stater, 14607
- Aids Care
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Lyons Cedex 04, Frankrig, 69317
- Local Institution
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Orleans Cedex 2, Frankrig, 45067
- Local Institution
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Paris, Frankrig, 75020
- Local Institution
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Paris Cedex 14, Frankrig, 75679
- Local Institution
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Strasbourg Cedex, Frankrig, 67091
- Local Institution
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Cedex 12
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Paris, Cedex 12, Frankrig, 75551
- Local Institution
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Genova, Italien, 16128
- Local Institution
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Genova, Italien, 16132
- Local Institution
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Milano, Italien, 20127
- Local Institution
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Milano, Italien, 20142
- Local Institution
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Roma, Italien, 00149
- Local Institution
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Warszawa, Polen, 01-201
- Local Institution
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Wroclaw, Polen, 50-136
- Local Institution
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Alicante, Spanien, 03010
- Local Institution
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Barcelona, Spanien, 08036
- Local Institution
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Madrid, Spanien, 28006
- Local Institution
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Madrid, Spanien, 28007
- Local Institution
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Madrid, Spanien, 28046
- Local Institution
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Madrid, Spanien, 28805
- Local Institution
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Bochum, Tyskland, 44791
- Local Institution
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Frankfurt, Tyskland, 60590
- Local Institution
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Frankfurt Am Main, Tyskland, 60311
- Local Institution
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Hamburg, Tyskland, 20246
- Local Institution
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Munich, Tyskland, 80336
- Local Institution
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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
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
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 |
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Eksperimentel: Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
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Capsules, Oral, 300mg, Once daily, 48 weeks
Andre navne:
Tablets, Oral, 100 mg, Once daily, 48 weeks
Andre navne:
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Andre navne:
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Andet: Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine |
Capsules, Oral, 300mg, Once daily, 48 weeks
Andre navne:
Tablets, Oral, 100 mg, Once daily, 48 weeks
Andre navne:
Tablets, Oral, 300/200 mg, Once daily, 48 weeks
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
Tidsramme: From Day 1 to Week 24
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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.
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From Day 1 to Week 24
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Tidsramme: From Day 1 to Week 48
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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.
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From Day 1 to Week 48
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Number of Participants With Virologic Rebound at Weeks 24 and 48
Tidsramme: Day 1 to Weeks 28 and 48
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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.
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Day 1 to Weeks 28 and 48
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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
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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
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Day 1 to Week 24
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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
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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
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Day 1 to Week 48
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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
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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.
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Day 1 to Week 48
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Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Tidsramme: From Baseline to Week 48
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LD=low-density lipoprotein; HDL=high-density lipoprotein.
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From Baseline to Week 48
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Bristol-Mayers Squibb, Bristol-Mayers Squibb
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. oktober 2011
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. februar 2014
Datoer for studieregistrering
Først indsendt
7. april 2011
Først indsendt, der opfyldte QC-kriterier
8. april 2011
Først opslået (Skøn)
11. april 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. februar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. februar 2015
Sidst verificeret
1. februar 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Reverse transkriptasehæmmere
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Proteasehæmmere
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- HIV-integrasehæmmere
- Integrasehæmmere
- HIV-proteasehæmmere
- Virale proteasehæmmere
- Tenofovir
- Emtricitabin
- Raltegravir kalium
- Ritonavir
- Atazanavirsulfat
Andre undersøgelses-id-numre
- AI424-402
- 2009-017032-41 (EudraCT nummer)
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 .
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