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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

129

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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))
Andere namen:
  • maraviroc =Celsentri, Selzentry; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia; darunavir=Prezista
Geneesmiddel: 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))
Andere namen:
  • maraviroc=Celsentri, Selzentry; emtricitabine/tenofovir=Truvada; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia
Experimenteel: 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.
Geneesmiddel: 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))
Andere namen:
  • maraviroc =Celsentri, Selzentry; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia; darunavir=Prezista
Geneesmiddel: 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))
Andere namen:
  • maraviroc=Celsentri, Selzentry; emtricitabine/tenofovir=Truvada; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HIV-1 RNA Levels at Baseline
Tijdsspanne: Baseline
Baseline
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, Week 16, Week 24, Week 48, Week 96
Baseline, Week 16, Week 24, Week 48, Week 96
Number of Participants With Genotypic Resistance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

ViiV Healthcare

Medewerkers

Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2009

Primaire voltooiing (Werkelijk)

1 juli 2010

Studie voltooiing (Werkelijk)

1 juli 2011

Studieregistratiedata

Eerst ingediend

21 januari 2009

Eerst ingediend dat voldeed aan de QC-criteria

21 januari 2009

Eerst geplaatst (Schatting)

22 januari 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

15 juni 2012

Laatste update ingediend die voldeed aan QC-criteria

8 juni 2012

Laatst geverifieerd

1 juni 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • A4001078

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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