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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Saint-Pierre, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

B/F/TAF

Drug

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

Other names: Biktarvy®

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

    Time frame: Week 24

    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.

Secondary outcomes

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

    Time frame: First dose date up to 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.

  2. Percentage of Participants Experiencing AEs Through Week 48

    Time frame: First dose date Up to 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.

  3. Percentage of Participants Experiencing AEs Through Week 72

    Time frame: First dose date Up to 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.

  4. Percentage of Participants Experiencing AEs Through Week 96

    Time frame: First dose date Up to 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.

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

    Time frame: Week 48

    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.

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

    Time frame: Week 72

    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.

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

    Time frame: Week 96

    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.

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

    Time frame: Baseline, Week 24

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

    Time frame: Baseline, Week 48

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 96

  12. Change From Baseline in CD4 Percentage at Week 24

    Time frame: Baseline, Week 24

  13. Change From Baseline in CD4 Percentage at Week 48

    Time frame: Baseline, Week 48

  14. Change From Baseline in CD4 Percentage at Week 72

    Time frame: Baseline, Week 72

  15. Change From Baseline in CD4 Percentage at Week 96

    Time frame: Baseline, Week 96

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

    Time frame: Week 24

    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.

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

    Time frame: Week 48

    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.

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

    Time frame: Week 72

    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.

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

    Time frame: Week 96

    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.

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

    Time frame: Week 24

    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).

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

    Time frame: Week 48

    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).

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

    Time frame: Week 72

    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).

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

    Time frame: Week 96

    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).

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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