A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects
NCT ID: NCT02431247
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
725 participants
INTERVENTIONAL
2015-07-06
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide
Subject will receive a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination \[FDC\]) once daily along with DRV/COBI FDC-matching and FTC/TDF FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (i.e. after last subject has reached Week 48). After Week 48 analysis unblinding visit, subjects will receive a single tablet containing D/C/F/TAF FDC once daily up to Week 96.
Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF) 10 mg will be administered once daily.
FTC/TDF FDC Matching Placebo
Matching placebo of FTC/TDF FDC will be administered once daily.
DRV/COBI FDC Matching Placebo
Matching placebo of DRV/COBI FDC will be administered once daily.
DRV/COBI fixed dose combination (FDC) and FTC/TDF FDC
Subject will receive DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding (i.e. after last subject has reached Week 48). After Week 48 analysis unblinding, subjects will receive a single tablet containing D/C/F/TAF FDC once daily up to Week 96.
DRV/COBI FDC
A tablet containing DRV 800 mg and COBI 150 mg will be administered once daily.
FTC/TDF FDC
A tablet containing FTC 200 mg and TDF 300 mg will be administered once daily.
D/C/F/TAF FDC - Matching Placebo
Matching placebo of D/C/F/TAF FDC will be administered once daily.
Interventions
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Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF) 10 mg will be administered once daily.
DRV/COBI FDC
A tablet containing DRV 800 mg and COBI 150 mg will be administered once daily.
FTC/TDF FDC
A tablet containing FTC 200 mg and TDF 300 mg will be administered once daily.
D/C/F/TAF FDC - Matching Placebo
Matching placebo of D/C/F/TAF FDC will be administered once daily.
FTC/TDF FDC Matching Placebo
Matching placebo of FTC/TDF FDC will be administered once daily.
DRV/COBI FDC Matching Placebo
Matching placebo of DRV/COBI FDC will be administered once daily.
Eligibility Criteria
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Inclusion Criteria
* Screening plasma HIV-1 ribonucleic acid (RNA) level greater than or equal to \>=1,000 copies per milliliter (copies/mL)
* Cluster of Differentiation 4+ (CD4+) cell count \>50 cells/microliter (cells/mcL)
* Screening HIV-1 genotype report must show full sensitivity to DRV, TDF and FTC
* Screening eGFRcreatinine \>=70 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Exclusion Criteria
* Subject has proven or suspected acute hepatitis within 30 days prior to screening
* Subject is hepatitis C or hepatitis B positive
* Subject has a history of cirrhosis
18 Years
ALL
No
Sponsors
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Janssen Sciences Ireland UC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Sciences Ireland UC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Sciences Ireland UC
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Bakersfield, California, United States
Long Beach, California, United States
Los Angeles, California, United States
North Hollywood, California, United States
San Francisco, California, United States
Washington D.C., District of Columbia, United States
Ft. Pierce, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Berkley, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Hillsborough, New Jersey, United States
Newark, New Jersey, United States
Somers Point, New Jersey, United States
Santa Fe, New Mexico, United States
Manhasset, New York, United States
Chapel Hill, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Seattle, Washington, United States
Antwerp, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Clamart, , France
Le Kremlin-Bicêtre, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Nantes, , France
Paris, , France
Strasbourg, , France
Tourcoing, , France
Berlin, , Germany
Bonn, , Germany
Cologne, , Germany
Essen, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Hanover, , Germany
München, , Germany
Bydgoszcz, , Poland
Chorzów, , Poland
Krakow, , Poland
Lodz, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
San Juan, , Puerto Rico
Krasnodar, , Russia
Oryol, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Smolensk, , Russia
Tolyatti, , Russia
Voronezh, , Russia
Yekaterinburg, , Russia
Alicante, , Spain
Badalona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Elche, , Spain
Madrid, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Valencia, , Spain
Brighton, , United Kingdom
Bristol, , United Kingdom
London, , United Kingdom
Countries
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References
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Ackaert O, McDougall D, Perez-Ruixo C, Perez-Ruixo JJ, Jezorwski J, Crauwels HM. Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies). AAPS J. 2021 Jun 7;23(4):82. doi: 10.1208/s12248-021-00607-8.
Orkin C, Eron JJ, Rockstroh J, Podzamczer D, Esser S, Vandekerckhove L, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Opsomer M; AMBER study group. Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2020 Apr 1;34(5):707-718. doi: 10.1097/QAD.0000000000002463.
Lathouwers E, Wong EY, Brown K, Baugh B, Ghys A, Jezorwski J, Mohsine EG, Van Landuyt E, Opsomer M, De Meyer S; AMBER and EMERALD Study Groups. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials. AIDS Res Hum Retroviruses. 2020 Jan;36(1):48-57. doi: 10.1089/AID.2019.0111. Epub 2019 Oct 21.
Rashbaum B, Spinner CD, McDonald C, Mussini C, Jezorwski J, Luo D, Van Landuyt E, Brown K, Wong EY. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive patients with HIV-1: subgroup analyses of the phase 3 AMBER study. HIV Res Clin Pract. 2019 Feb;20(1):24-33. doi: 10.1080/15284336.2019.1608714. Epub 2019 May 29.
Eron JJ, Orkin C, Gallant J, Molina JM, Negredo E, Antinori A, Mills A, Reynes J, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Vanveggel S, Opsomer M; AMBER study group. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2018 Jul 17;32(11):1431-1442. doi: 10.1097/QAD.0000000000001817.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TMC114FD2HTX3001
Identifier Type: OTHER
Identifier Source: secondary_id
2015-000754-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR107277
Identifier Type: -
Identifier Source: org_study_id
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