A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
8 juni 2012 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
129
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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Los Angeles, California, Förenta staterna, 90048
- Pfizer Investigational Site
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Los Angeles, California, Förenta staterna, 90069
- Pfizer Investigational Site
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Los Angeles, California, Förenta staterna, 90027
- Pfizer Investigational Site
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Los Angeles, California, Förenta staterna, 90028
- Pfizer Investigational Site
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Connecticut
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Norwalk, Connecticut, Förenta staterna, 06851
- Pfizer Investigational Site
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20009
- Pfizer Investigational Site
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Florida
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Miami, Florida, Förenta staterna, 33136
- Pfizer Investigational Site
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Miami, Florida, Förenta staterna, 33133
- Pfizer Investigational Site
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Miami, Florida, Förenta staterna, 33137
- Pfizer Investigational Site
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Orlando, Florida, Förenta staterna, 32803
- Pfizer Investigational Site
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Pensacola, Florida, Förenta staterna, 32504
- Pfizer Investigational Site
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St. Petersburg, Florida, Förenta staterna, 33713
- Pfizer Investigational Site
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Tampa, Florida, Förenta staterna, 33602
- Pfizer Investigational Site
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Tampa, Florida, Förenta staterna, 33614
- Pfizer Investigational Site
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Georgia
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Atlanta, Georgia, Förenta staterna, 30312
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, Förenta staterna, 60657
- Pfizer Investigational Site
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Massachusetts
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Springfield, Massachusetts, Förenta staterna, 01107
- Pfizer Investigational Site
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Springfield, Massachusetts, Förenta staterna, 01199
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- Pfizer Investigational Site
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68106
- Pfizer Investigational Site
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New York
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New York, New York, Förenta staterna, 10003
- Pfizer Investigational Site
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North Carolina
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Huntersville, North Carolina, Förenta staterna, 28078
- Pfizer Investigational Site
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Texas
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Addison, Texas, Förenta staterna, 75001
- Pfizer Investigational Site
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Dallas, Texas, Förenta staterna, 75204
- Pfizer Investigational Site
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Dallas, Texas, Förenta staterna, 75390
- Pfizer Investigational Site
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Houston, Texas, Förenta staterna, 77098
- Pfizer Investigational Site
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Washington
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Spokane, Washington, Förenta staterna, 99204
- Pfizer Investigational Site
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Alicante, Spanien, 03010
- Pfizer Investigational Site
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Barcelona, Spanien, 08036
- Pfizer Investigational Site
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Cordoba, Spanien, 14004
- Pfizer Investigational Site
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Madrid, Spanien, 28046
- Pfizer Investigational Site
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Sevilla, Spanien, 41013
- Pfizer Investigational Site
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Barcelona
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L'hospitalet de Llobregat, Barcelona, Spanien, 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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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
16 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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 |
|---|---|
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Experimentell: 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))
Andra namn:
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))
Andra namn:
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Experimentell: 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))
Andra namn:
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))
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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)
Tidsram: Week 48
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Week 48
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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HIV-1 RNA Levels at Baseline
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Baseline to Week 96 or Time of treatment Failure
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
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 mars 2009
Primärt slutförande (Faktisk)
1 juli 2010
Avslutad studie (Faktisk)
1 juli 2011
Studieregistreringsdatum
Först inskickad
21 januari 2009
Först inskickad som uppfyllde QC-kriterierna
21 januari 2009
Första postat (Uppskatta)
22 januari 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
15 juni 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 juni 2012
Senast verifierad
1 juni 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunologiska bristsyndrom
- Immunsystemets sjukdomar
- Långsamma virussjukdomar
- HIV-infektioner
- Förvärvat immunbristsyndrom
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Omvända transkriptashämmare
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Anti-HIV-medel
- Antiretrovirala medel
- Proteashämmare
- Cytokrom P-450 CYP3A-hämmare
- Cytokrom P-450 enzymhämmare
- HIV-proteashämmare
- Virala proteashämmare
- HIV-fusionshämmare
- Virala fusionsproteinhämmare
- CCR5-receptorantagonister
- Tenofovir
- Emtricitabin
- Ritonavir
- Lopinavir
- Maraviroc
- Darunavir
- Atazanavirsulfat
Andra studie-ID-nummer
- A4001078
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 .