Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
NCT ID: NCT03405935
Last Updated: 2020-12-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
86 participants
INTERVENTIONAL
2018-03-01
2020-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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B/F/TAF
B/F/TAF FDC for at least 96 weeks.
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food.
Interventions
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B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented plasma HIV-1 ribonucleic acid (RNA) \< 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \[NCT02616783\]) for the last 2 visits preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
* Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Exclusion Criteria
* Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
* Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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CHU Saint-Pierre
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Hopital Saint-Andre
Bordeaux, , France
Hopital Europeen Marseille
Marseille, , France
C.H.U. de Nantes - Hotel Dieu
Nantes, , France
CHU de Nice
Nice, , France
Hopital Necker - Enfants Malades
Paris, , France
Hopital Saint Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
Interne et Maladies infectieuses
Pessac, , France
CH de Tourcoing
Tourcoing, , France
ASST Papa Giovanni XXIII
Bergamo, , Italy
ASST - Fatebenefratelli Sacco
Milan, , Italy
P.O. Spirito Santo - U.O. Malattie Infettive e Tropicali
Pescara, , Italy
IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Roma, , Italy
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Costa Del Sol
Marbella, , Spain
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Maggiolo F, Rizzardini G, Molina JM, Pulido F, De Wit S, Vandekerckhove L, Berenguer J, D'Antoni ML, Blair C, Chuck SK, Piontkowsky D, Martin H, Haubrich R, McNicholl IR, Gallant J. Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV: Results of a 96-week, phase 3b, open-label, switch trial in virologically suppressed people >/=65 years of age. HIV Med. 2023 Jan;24(1):27-36. doi: 10.1111/hiv.13319. Epub 2022 May 8.
Maggiolo F, Rizzardini G, Molina JM, Pulido F, De Wit S, Vandekerckhove L, Berenguer J, D'Antoni ML, Blair C, Chuck SK, Piontkowsky D, Martin H, Haubrich R, McNicholl IR, Gallant J. Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged >/= 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial. Infect Dis Ther. 2021 Jun;10(2):775-788. doi: 10.1007/s40121-021-00419-5. Epub 2021 Mar 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003428-61
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-380-4449
Identifier Type: -
Identifier Source: org_study_id