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

NCT03405935 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: GS-US-380-44492017-003428-61
• Study Type: interventional
• Target: 86
• Locations: 5 countries
• Sites: 25

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.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• 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

  The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.

  Week 24

Secondary Outcomes (23)

• Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24

  First dose date up to Week 24

• Percentage of Participants Experiencing AEs Through Week 48

  First dose date Up to Week 48

• Percentage of Participants Experiencing AEs Through Week 72

  First dose date Up to Week 72

• Percentage of Participants Experiencing AEs Through Week 96

  First dose date Up to Week 96

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm

  Week 48

Study Arms (1)

B/F/TAF

EXPERIMENTAL

B/F/TAF FDC for at least 96 weeks.

Drug: B/F/TAF

Interventions

B/F/TAF DRUG

50/200/25 mg FDC tablet administered orally once daily without regard to food.

Also known as: Biktarvy®

B/F/TAF

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (25)

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Hopital Saint-Andre

Bordeaux, 33075, France

Location

Hopital Europeen Marseille

Marseille, 13006, France

Location

C.H.U. de Nantes - Hotel Dieu

Nantes, 44093, France

Location

CHU de Nice

Nice, 6203, France

Location

Hopital Necker - Enfants Malades

Paris, 75015, France

Location

Hopital Saint Louis

Paris, 75475, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Interne et Maladies infectieuses

Pessac, 33064, France

Location

CH de Tourcoing

Tourcoing, 59208, France

Location

ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

ASST - Fatebenefratelli Sacco

Milan, 20157, Italy

Location

P.O. Spirito Santo - U.O. Malattie Infettive e Tropicali

Pescara, 65124, Italy

Location

IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

Roma, 00149, Italy

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 8916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Costa Del Sol

Marbella, 29603, Spain

Location

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35527425 DERIVED

• 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.

  PMID: 33686573 DERIVED

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: March 1, 2018
• Primary Completion: November 20, 2018
• Study Completion: May 29, 2020
• Last Updated: December 1, 2020
• Results First Posted: December 5, 2019

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

BE (2); FR (9); IT (4); GB (1); ES (9)