A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
8. juni 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
129
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Los Angeles, California, Forente stater, 90048
- Pfizer Investigational Site
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Los Angeles, California, Forente stater, 90069
- Pfizer Investigational Site
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Los Angeles, California, Forente stater, 90027
- Pfizer Investigational Site
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Los Angeles, California, Forente stater, 90028
- Pfizer Investigational Site
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Connecticut
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Norwalk, Connecticut, Forente stater, 06851
- Pfizer Investigational Site
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District of Columbia
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Washington, District of Columbia, Forente stater, 20009
- Pfizer Investigational Site
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Florida
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Miami, Florida, Forente stater, 33136
- Pfizer Investigational Site
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Miami, Florida, Forente stater, 33133
- Pfizer Investigational Site
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Miami, Florida, Forente stater, 33137
- Pfizer Investigational Site
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Orlando, Florida, Forente stater, 32803
- Pfizer Investigational Site
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Pensacola, Florida, Forente stater, 32504
- Pfizer Investigational Site
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St. Petersburg, Florida, Forente stater, 33713
- Pfizer Investigational Site
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Tampa, Florida, Forente stater, 33602
- Pfizer Investigational Site
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Tampa, Florida, Forente stater, 33614
- Pfizer Investigational Site
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Georgia
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Atlanta, Georgia, Forente stater, 30312
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, Forente stater, 60657
- Pfizer Investigational Site
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Massachusetts
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Springfield, Massachusetts, Forente stater, 01107
- Pfizer Investigational Site
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Springfield, Massachusetts, Forente stater, 01199
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Pfizer Investigational Site
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Nebraska
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Omaha, Nebraska, Forente stater, 68106
- Pfizer Investigational Site
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New York
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New York, New York, Forente stater, 10003
- Pfizer Investigational Site
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North Carolina
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Huntersville, North Carolina, Forente stater, 28078
- Pfizer Investigational Site
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Texas
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Addison, Texas, Forente stater, 75001
- Pfizer Investigational Site
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Dallas, Texas, Forente stater, 75204
- Pfizer Investigational Site
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Dallas, Texas, Forente stater, 75390
- Pfizer Investigational Site
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Houston, Texas, Forente stater, 77098
- Pfizer Investigational Site
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Washington
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Spokane, Washington, Forente stater, 99204
- Pfizer Investigational Site
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Alicante, Spania, 03010
- Pfizer Investigational Site
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Barcelona, Spania, 08036
- Pfizer Investigational Site
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Cordoba, Spania, 14004
- Pfizer Investigational Site
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Madrid, Spania, 28046
- Pfizer Investigational Site
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Sevilla, Spania, 41013
- Pfizer Investigational Site
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Barcelona
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L'hospitalet de Llobregat, Barcelona, Spania, 08907
- Pfizer Investigational Site
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Berlin, Tyskland, 12157
- Pfizer Investigational Site
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Berlin, Tyskland, 10243
- Pfizer Investigational Site
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Frankfurt am Main, Tyskland, 60590
- Pfizer Investigational Site
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Hamburg, Tyskland, 20146
- Pfizer Investigational Site
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Koeln, Tyskland, 50937
- Pfizer Investigational Site
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Muenchen, Tyskland, 80335
- Pfizer Investigational Site
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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
16 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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 |
|---|---|
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Eksperimentell: 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.
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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 navn:
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 navn:
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Eksperimentell: 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. |
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 navn:
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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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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
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Week 48
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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HIV-1 RNA Levels at Baseline
Tidsramme: Baseline
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Baseline
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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
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Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.
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Baseline , Days 4, 7, 10 and 14
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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)
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Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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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)
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Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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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)
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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).
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Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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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
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Baseline, Week 16, Week 24, Week 48, Week 96
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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
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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
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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
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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
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Time to Loss of Virological Response (TLOVR)
Tidsramme: Baseline through Week 96
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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.
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Baseline through Week 96
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Time-Averaged Difference (TAD) in log10 Viral Load
Tidsramme: Week 16, Week 24, Week 48, Week 96
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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).
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Week 16, Week 24, Week 48, Week 96
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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
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Baseline, Week 16, Week 24, Week 48, Week 96
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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
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Baseline, Week 16, Week 24, Week 48, Week 96
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Number of Participants With Genotypic Resistance
Tidsramme: Week 96 or Time of treatment failure
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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.
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Week 96 or Time of treatment failure
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Number of Participants With Phenotypic Resistance
Tidsramme: Week 96 or Time of treatment failure
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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.
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Week 96 or Time of treatment failure
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Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Tidsramme: Baseline to Week 96 or Time of treatment Failure
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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.
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Baseline to Week 96 or Time of treatment Failure
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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. mars 2009
Primær fullføring (Faktiske)
1. juli 2010
Studiet fullført (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først innsendt
21. januar 2009
Først innsendt som oppfylte QC-kriteriene
21. januar 2009
Først lagt ut (Anslag)
22. januar 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
15. juni 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2012
Sist bekreftet
1. juni 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Revers transkriptasehemmere
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Proteasehemmere
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- HIV-proteasehemmere
- Virale proteasehemmere
- HIV-fusjonshemmere
- Virale fusjonsproteinhemmere
- CCR5-reseptorantagonister
- Tenofovir
- Emtricitabin
- Ritonavir
- Lopinavir
- Maraviroc
- Darunavir
- Atazanavirsulfat
Andre studie-ID-numre
- A4001078
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. .