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Trial record 1 of 1 for:    GS-US-380-1474
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B/F/TAF FDC in HIV-1 Infected Virologically Suppressed Adolescents and Children

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ClinicalTrials.gov Identifier: NCT02881320
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

Cohort 1 and 2:

The primary objectives of this study are:

Part A:

- To evaluate the steady state pharmacokinetics (PK) of bictegravir (BIC) and confirm the dose of the bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years of age)

Parts A and B:

- To evaluate the safety and tolerability of the adult strength B/F/TAF FDC through Week 24 in HIV-1 infected, virologically suppressed adolescents (12 to <18 years of age) and children (6 to <12 years of age)

Cohort 3:

The primary objectives of this study are:

Part A:

- To evaluate the steady state PK of BIC and confirm the dose of B/F/TAF 30/120/15 mg FDC in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg

Parts A and B:

- To evaluate the safety and tolerability of the low dose B/F/TAF FDC tablet through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg


Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: B/F/TAF (Adult Strength) Drug: B/F/TAF (Low Dose) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Virologically Suppressed Adolescents and Children
Actual Study Start Date : September 21, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg)
  • Part A: Participate will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48.
  • Part B: Following confirmation of BIC PK data from Cohort 1 Part A, participants will receive the adult strength B/F/TAF through Week 48.
Drug: B/F/TAF (Adult Strength)
50/200/25 mg FDC tablets administered orally once daily without regard to food
Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

Experimental: Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg)
  • Part A: Participate will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48.
  • Part B: Following confirmation of BIC PK data from Cohort 2 Part A, participants will receive the adult strength B/F/TAF FDC through Week 48.
Drug: B/F/TAF (Adult Strength)
50/200/25 mg FDC tablets administered orally once daily without regard to food
Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

Experimental: Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg)
  • Part A: Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive the low dose B/F/TAF FDC tablet through Week 48.
  • Part B: Following confirmation of BIC PK data from Cohort 3 Part A, participants will receive the low dose B/F/TAF FDC tablet through Week 48.
Drug: B/F/TAF (Low Dose)
30/120/15 mg FDC tablets administered orally once daily without regard to food
Other Name: GS-9883/F/TAF

Experimental: Open-Label Extension
Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF FDC until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program.
Drug: B/F/TAF (Adult Strength)
50/200/25 mg FDC tablets administered orally once daily without regard to food
Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

Drug: B/F/TAF (Low Dose)
30/120/15 mg FDC tablets administered orally once daily without regard to food
Other Name: GS-9883/F/TAF




Primary Outcome Measures :
  1. PK Parameter: AUCtau of Bictegravir [ Time Frame: Week 2 (all Cohorts) or Week 4 (Cohort 1 and Cohort 2 Part A participants only) ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

  2. PK Parameter: Ctau of Bictegravir [ Time Frame: Week 2 (all Cohorts) or Week 4 (Cohort 1 and Cohort 2 Part A participants only) ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  3. Incidence of Treatment-Emergent Adverse Events (AEs) Through Week 24 [ Time Frame: Up to 24 weeks ]
  4. Incidence of Treatment-Emergent Laboratory Abnormalities Through Week 24 [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 24 ]
  2. Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
  3. Change from Baseline in CD4+ Cell Counts at Week 24 [ Time Frame: Week 24 ]
  4. Change from Baseline in CD4+ Cell Counts at Week 48 [ Time Frame: Week 48 ]
  5. Change from Baseline in CD4+ Cell Count Percentages at Week 24 [ Time Frame: Week 24 ]
  6. Change from Baseline in CD4+ Cell Count Percentages at Week 48 [ Time Frame: Week 48 ]
  7. PK Parameter: Tmax of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    Tmax is defined as the time (observed time point) of Cmax.

  8. PK Parameter: Cmax of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    Cmax is defined as the maximum observed concentration of drug.

  9. PK Parameter: AUClast of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  10. PK Parameter: T1/2 of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

  11. PK Parameter: Apparent Clearance (CL) of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    CL is defined as the systemic clearance of the drug following study drug administration.

  12. PK Parameter: Apparent Vz of Bictegravir [ Time Frame: Week 2 or Week 4 ]
    Vz is defined as the volume of distribution of the drug after study drug administration.

  13. PK Parameter: AUCtau of TAF and FTC [ Time Frame: Week 2 or Week 4 ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

  14. PK Parameter: AUClast of TAF and FTC [ Time Frame: Week 2 or Week 4 ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  15. PK Parameter: Cmax of TAF and FTC [ Time Frame: Week 2 or Week 4 ]
    Cmax is defined as the maximum observed concentration of drug.

  16. PK Parameter: Ctau of TAF and FTC [ Time Frame: Week 2 or Week 4 ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  17. PK Parameter: Tmax of TAF and FTC [ Time Frame: Week 2 or Week 4 ]
    Tmax is defined as the time (observed time point) of Cmax.

  18. PK Parameter: T1/2 of TAF and FTC [ Time Frame: Week 2 or Week 4 ]
    T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

  19. PK Parameter: Apparent CL of TAF and FTC [ Time Frame: Week 2 or Week 4 ]
    CL is defined as the systemic clearance of the drug following study drug administration.

  20. PK Parameter: Apparent Vz of TAF and FTC [ Time Frame: Week 2 or Week 4 ]
    Vz is defined as the volume of distribution of the drug after study drug administration.

  21. Percentage of Participants Experiencing Treatment-Emergent Adverse Events Through the Study [ Time Frame: Up to 48 weeks ]
  22. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through the Study [ Time Frame: Up to 48 weeks ]
  23. Acceptability and Palatability of B/F/TAF Formulation at Day 1 (All Cohorts) [ Time Frame: Day 1 ]
    Participants will be asked if the study drug was palatable and if they were able to take the dosage form.

  24. Acceptability and Palatability of B/F/TAF Formulation at Week 4 (All Cohorts) [ Time Frame: Week 4 ]
    Participants will be asked if the study drug was palatable and if they were able to take the dosage form.

  25. Acceptability and Palatability of B/F/TAF Formulation at Week 24 (Cohort 3) [ Time Frame: Week 24 ]
    Participants will be asked if the study drug was palatable and if they were able to take the dosage form.

  26. Acceptability and Palatability of B/F/TAF Formulation at Week 48 (Cohort 3) [ Time Frame: Week 48 ]
    Participants will be asked if the study drug was palatable and if they were able to take the dosage form.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

Cohort 1: HIV-1 infected adolescents (12 to < 18 years of age and screening weight ≥ 35 kg) who are virologically suppressed for ≥ 6 months prior to screening.

Cohort 2: HIV-1 infected children (6 to < 12 years of age and screening weight ≥ 25 kg) who are virologically suppressed for ≥ 6 months prior to screening.

Cohort 3: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to < 25 kg) who are virologically suppressed for ≥ 6 months prior to screening.

  • Documented plasma HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the Screening visit. Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests.
  • Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen.
  • Estimated glomerular filtration rate (GFR) ≥ 90 mL/min/1.73 m^2 according to the Schwartz Formula
  • No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881320


Contacts
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Contact: Gilead Study Team GS-US-380-1474@gilead.com

Locations
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United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Active, not recruiting
Fort Pierce, Florida, United States, 34982
Recruiting
Jacksonville, Florida, United States, 32209
Recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Active, not recruiting
New York, New York, United States, 10016
United States, North Carolina
Recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
Recruiting
Memphis, Tennessee, United States, 38105
South Africa
Recruiting
Bloemfontein, South Africa, 9301
Recruiting
Cape Town, South Africa, 7505
Recruiting
Cape Town, South Africa, 7646
Recruiting
Dundee, South Africa, 3000
Recruiting
Durban, South Africa, 4302
Recruiting
Johannesburg, South Africa, 2112
Recruiting
Pretoria, South Africa, 0089
Recruiting
Soweto, South Africa, 2013
Thailand
Recruiting
Bangkok, Thailand, 10330
Recruiting
Bangkok, Thailand, 10700
Recruiting
Khon Kaen, Thailand, 40002
Uganda
Recruiting
Kampala, Uganda
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02881320     History of Changes
Other Study ID Numbers: GS-US-380-1474
2016-002345-39 ( EudraCT Number )
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No