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A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

8. juni 2012 opdateret af: ViiV Healthcare

Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1

This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

129

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90069
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90027
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90028
        • Pfizer Investigational Site
    • Connecticut
      • Norwalk, Connecticut, Forenede Stater, 06851
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20009
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Pfizer Investigational Site
      • Miami, Florida, Forenede Stater, 33133
        • Pfizer Investigational Site
      • Miami, Florida, Forenede Stater, 33137
        • Pfizer Investigational Site
      • Orlando, Florida, Forenede Stater, 32803
        • Pfizer Investigational Site
      • Pensacola, Florida, Forenede Stater, 32504
        • Pfizer Investigational Site
      • St. Petersburg, Florida, Forenede Stater, 33713
        • Pfizer Investigational Site
      • Tampa, Florida, Forenede Stater, 33602
        • Pfizer Investigational Site
      • Tampa, Florida, Forenede Stater, 33614
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30312
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60657
        • Pfizer Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01107
        • Pfizer Investigational Site
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68106
        • Pfizer Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10003
        • Pfizer Investigational Site
    • North Carolina
      • Huntersville, North Carolina, Forenede Stater, 28078
        • Pfizer Investigational Site
    • Texas
      • Addison, Texas, Forenede Stater, 75001
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75204
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75390
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77098
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, Forenede Stater, 99204
        • Pfizer Investigational Site
  • Spanien
      • Alicante, Spanien, 03010
        • Pfizer Investigational Site
      • Barcelona, Spanien, 08036
        • Pfizer Investigational Site
      • Cordoba, Spanien, 14004
        • Pfizer Investigational Site
      • Madrid, Spanien, 28046
        • Pfizer Investigational Site
      • Sevilla, Spanien, 41013
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spanien, 08907
        • Pfizer Investigational Site
  • Tyskland
      • Berlin, Tyskland, 12157
        • Pfizer Investigational Site
      • Berlin, Tyskland, 10243
        • Pfizer Investigational Site
      • Frankfurt am Main, Tyskland, 60590
        • Pfizer Investigational Site
      • Hamburg, Tyskland, 20146
        • Pfizer Investigational Site
      • Koeln, Tyskland, 50937
        • Pfizer Investigational Site
      • Muenchen, Tyskland, 80335
        • Pfizer Investigational Site

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

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.
  • CD4 count ≥100 cells/mm3 at Screening.
  • Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity.

Exclusion Criteria:

  • Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
  • Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.
  • X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.

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
Eksperimentel: Arm A
maraviroc (Selzentry, Celsentri) 150 mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir (Reyataz) in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir (Prezista)/ritonavir (Norvir)((800/100 mg) QD or lopinavir/ritonavir (Kaletra, Aluvia)(400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir (Prezista)/ritonavir (Norvir) or lopinavir/ritonavir (Kaletra, Aluvia)(, then the subject must be discontinued from the study.
Medicin: maraviroc
maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
Andre navne:
  • maraviroc =Celsentri, Selzentry; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia; darunavir=Prezista
Medicin: maraviroc
emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
Andre navne:
  • maraviroc=Celsentri, Selzentry; emtricitabine/tenofovir=Truvada; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia
Eksperimentel: Arm B

emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD

Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study.
Medicin: maraviroc
maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
Andre navne:
  • maraviroc =Celsentri, Selzentry; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia; darunavir=Prezista
Medicin: maraviroc
emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
Andre navne:
  • maraviroc=Celsentri, Selzentry; emtricitabine/tenofovir=Truvada; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
Tidsramme: Week 48
Week 48

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HIV-1 RNA Levels at Baseline
Tidsramme: Baseline
Baseline
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Tidsramme: Baseline , Days 4, 7, 10 and 14
Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.
Baseline , Days 4, 7, 10 and 14
Maximum Observed Plasma Concentration (Cmax) of Maraviroc
Tidsramme: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Minimum Observed Plasma Concentration (Cmin) of Maraviroc
Tidsramme: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Average Observed Plasma Concentration (Cavg) of Maraviroc
Tidsramme: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).
Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
Tidsramme: Baseline, Week 16, Week 24, Week 48, Week 96
Baseline, Week 16, Week 24, Week 48, Week 96
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Tidsramme: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Tidsramme: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Time to Loss of Virological Response (TLOVR)
Tidsramme: Baseline through Week 96
TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.
Baseline through Week 96
Time-Averaged Difference (TAD) in log10 Viral Load
Tidsramme: Week 16, Week 24, Week 48, Week 96
TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).
Week 16, Week 24, Week 48, Week 96
Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
Tidsramme: Baseline, Week 16, Week 24, Week 48, Week 96
Baseline, Week 16, Week 24, Week 48, Week 96
Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
Tidsramme: Baseline, Week 16, Week 24, Week 48, Week 96
Baseline, Week 16, Week 24, Week 48, Week 96
Number of Participants With Genotypic Resistance
Tidsramme: Week 96 or Time of treatment failure
Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Week 96 or Time of treatment failure
Number of Participants With Phenotypic Resistance
Tidsramme: Week 96 or Time of treatment failure
Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Week 96 or Time of treatment failure
Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Tidsramme: Baseline to Week 96 or Time of treatment Failure
Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.
Baseline to Week 96 or Time of treatment Failure

Samarbejdspartnere og efterforskere

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

Sponsor

ViiV Healthcare

Samarbejdspartnere

Pfizer

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 2009

Primær færdiggørelse (Faktiske)

1. juli 2010

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

21. januar 2009

Først indsendt, der opfyldte QC-kriterier

21. januar 2009

Først opslået (Skøn)

22. januar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. juni 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2012

Sidst verificeret

1. juni 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A4001078

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 Human Immunodeficiency Virus-1

Kliniske forsøg med maraviroc

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Brazil

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner