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HIV-1 InfectionPhase 3NCT03405935

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

A Phase 3 study testing B/F/TAF in people with HIV-1 Infection, run by Gilead Sciences at 25 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
B/F/TAF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
25 sitesin 5 countries
Study dates
1 Mar 2018to 29 May 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

France9 sites
  • Hopital Saint-Andre

    Bordeaux, 33075

  • Hopital Europeen Marseille

    Marseille, 13006

  • C.H.U. de Nantes - Hotel Dieu

    Nantes, 44093

  • CHU de Nice

    Nice, 6203

  • Hopital Necker - Enfants Malades

    Paris, 75015

  • Hopital Saint Louis

    Paris, 75475

  • Hopital Saint Antoine

    Paris, 75571

  • Interne et Maladies infectieuses

    Pessac, 33064

  • CH de Tourcoing

    Tourcoing, 59208

Other trials in France

Spain9 sites
  • Hospital Universitari Germans Trias i Pujol

    Badalona, 8916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08026

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Costa Del Sol

    Marbella, 29603

Other trials in Spain

Italy4 sites
  • ASST Papa Giovanni XXIII

    Bergamo, 24127

  • ASST - Fatebenefratelli Sacco

    Milan, 20157

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

    Pescara, 65124

  • IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

    Roma, 00149

Other trials in Italy

Belgium2 sites
  • CHU Saint-Pierre

    Brussels, 1000

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

United Kingdom1 site
  • Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

About this study

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

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
Being tested
B/F/TAF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B/F/TAFDrug

    Also called Biktarvy®

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

Study groups in NCT03405935
Study groupRoleWhat they receive
B/F/TAFExperimentalB/F/TAF FDC for at least 96 weeks.
Receives: Drug: B/F/TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 24

Secondary outcomes (23)
  1. Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24

    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.

    Measured: First dose date up to Week 24

  2. Percentage of Participants Experiencing AEs Through Week 48

    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.

    Measured: First dose date Up to Week 48

  3. Percentage of Participants Experiencing AEs Through Week 72

    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.

    Measured: First dose date Up to Week 72

  4. Percentage of Participants Experiencing AEs Through Week 96

    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.

    Measured: First dose date Up to Week 96

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

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 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.

    Measured: Week 48

  6. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 72 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.

    Measured: Week 72

  7. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA-Defined Snapshot Algorithm

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 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.

    Measured: Week 96

  8. Change From Baseline in CD4 Cell Count at Week 24

    Measured: Baseline, Week 24

  9. Change From Baseline in CD4 Cell Count at Week 48

    Measured: Baseline, Week 48

  10. Change From Baseline in CD4 Cell Count at Week 72

    Measured: Baseline, Week 72

  11. Change From Baseline in CD4 Cell Count at Week 96

    Measured: Baseline, Week 96

  12. Change From Baseline in CD4 Percentage at Week 24

    Measured: Baseline, Week 24

  13. Change From Baseline in CD4 Percentage at Week 48

    Measured: Baseline, Week 48

  14. Change From Baseline in CD4 Percentage at Week 72

    Measured: Baseline, Week 72

  15. Change From Baseline in CD4 Percentage at Week 96

    Measured: Baseline, Week 96

  16. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Failure Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.

    Measured: Week 24

  17. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Failure Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.

    Measured: Week 48

  18. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Failure Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 72 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.

    Measured: Week 72

  19. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Failure Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.

    Measured: Week 96

  20. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Excluded Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

    Measured: Week 24

  21. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Excluded Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

    Measured: Week 48

  22. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Excluded Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 72 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

    Measured: Week 72

  23. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Excluded Approach

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

    Measured: Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start1 Mar 2018
  3. Primary completion20 Nov 2018
  4. Study completion29 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03405935
Sponsor's protocol ID
GS-US-380-4449
Other IDs
2017-003428-61, 2017
Status last verified
Nov 2020
First submitted
12 Jan 2018
Last updated
1 Dec 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Publications

  • 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.

    PubMed 35527425
  • 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.

    PubMed 33686573

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing B/F/TAF in people with HIV-1 Infection, run by Gilead Sciences at 25 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France, Spain, Italy, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03405935, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.

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