Clinical trial NCT03405935: 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
Official title: A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1 Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 86
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.


Eligibility criteria: Key Inclusion Criteria:

* Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine \[FTC\]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \[NCT02616783\]) for ≥ 3 months
* 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

Key Exclusion Criteria:

* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
* Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
* Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24
timeFrame: First dose date up to Week 24
measure: Percentage of Participants Experiencing AEs Through Week 48
timeFrame: First dose date Up to Week 48
measure: Percentage of Participants Experiencing AEs Through Week 72
timeFrame: First dose date Up to Week 72
measure: Percentage of Participants Experiencing AEs Through Week 96
timeFrame: First dose date Up to Week 96
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm
timeFrame: Week 48
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm
timeFrame: Week 72
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA-Defined Snapshot Algorithm
timeFrame: Week 96
measure: Change From Baseline in CD4 Cell Count at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CD4 Cell Count at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in CD4 Cell Count at Week 72
timeFrame: Baseline, Week 72
measure: Change From Baseline in CD4 Cell Count at Week 96
timeFrame: Baseline, Week 96
measure: Change From Baseline in CD4 Percentage at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CD4 Percentage at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in CD4 Percentage at Week 72
timeFrame: Baseline, Week 72
measure: Change From Baseline in CD4 Percentage at Week 96
timeFrame: Baseline, Week 96
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Failure Approach
timeFrame: Week 24
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Failure Approach
timeFrame: Week 48
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Failure Approach
timeFrame: Week 72
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Failure Approach
timeFrame: Week 96
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Excluded Approach
timeFrame: Week 24
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Excluded Approach
timeFrame: Week 48
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Excluded Approach
timeFrame: Week 72
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Excluded Approach
timeFrame: Week 96
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Ghent
country: Belgium
facility: UZ Gent
city: Bordeaux
country: France
facility: Hopital Saint-Andre
city: Marseille
country: France
facility: Hopital Europeen Marseille
city: Nantes
country: France
facility: C.H.U. de Nantes - Hotel Dieu
city: Nice
country: France
facility: CHU de Nice
city: PARIS cedex 10
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Necker - Enfants Malades
city: Paris
country: France
facility: Hopital Saint Antoine
city: Pessac
country: France
facility: Interne et Maladies infectieuses
city: Tourcoing
country: France
facility: CH de Tourcoing
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Milano
country: Italy
facility: ASST - Fatebenefratelli Sacco
city: Pescara
country: Italy
facility: P.O. Spirito Santo - U.O. Malattie Infettive e Tropicali
city: Roma
country: Italy
facility: IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Marbella
country: Spain
facility: Hospital Costa Del Sol
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.