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B/F/TAF FDC in HIV-1 Infected Adolescents and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02881320
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : November 16, 2020
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

Cohort 4:

Group 1:

The primary objective of this study is:

  • To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg FDC TOS (administration of 2 B/F/TAF 15/60/7.5 mg FDC tablets for oral suspension (TOS)) through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets

Group 2:

The primary objectives of this study are:

  • To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 15/60/7.5 mg FDC TOS in HIV-1 infected children ≥ 1 month of age, on antiretroviral (ARV) treatment or treatment naive, weighing ≥ 10 to < 14 kg
  • To evaluate the safety and tolerability of the B/F/TAF 15/60/7.5 mg FDC TOS through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

Group 3:

The primary objectives of this study are:

  • To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg FDC TOS (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg
  • To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg FDC TOS (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

Group 4:

The primary objectives of this study are:

  • To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg FDC TOS in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg
  • To evaluate the safety and tolerability of the B/F/TAF 3.75/15/1.88 mg FDC TOS through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 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 Adolescents and Children
Actual Study Start Date : September 21, 2016
Estimated Primary Completion Date : July 31, 2022
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: Participants 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: Participants 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: Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg)

Due to Cohort 3 Part A Intensive PK evaluation at Week 2 with the low dose B/F/TAF FDC tablet, participants will not participate in an Intensive PK evaluation at Week 2.

Participants will receive B/F/TAF FDC tablets for oral suspension (TOS) through Week 48.

Drug: B/F/TAF (TOS)
2 x FDC of bictegravir 15 mg/emtricitabine 60 mg/ tenofovir alafenamide 7.5 mg (B/F/TAF 15/60/7.5 mg) (total dose 30/120/15 mg) administered orally as TOS, once daily without regard to food
Other Name: GS-9883/F/TAF

Experimental: Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg)
Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS through Week 48.
Drug: B/F/TAF (TOS)
FDC of bictegravir 15 mg/emtricitabine 60 mg/ tenofovir alafenamide 7.5 mg (B/F/TAF 15/60/7.5 mg) administered orally as TOS, once daily without regard to food
Other Name: GS-9883/F/TAF

Experimental: Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg)
Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS through Week 48.
Drug: B/F/TAF (TOS)
2 x FDC of bictegravir 3.75 mg/emtricitabine 15 mg/ tenofovir alafenamide 1.88 mg (B/F/TAF 3.75/15/1.88 mg) (total dose 7.5/30/3.75 mg) administered orally as TOS, once daily without regard to food
Other Name: GS-9883/F/TAF

Experimental: Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg)
Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS through Week 48.
Drug: B/F/TAF (TOS)
FDC of bictegravir 3.75 mg/emtricitabine 15 mg/ tenofovir alafenamide 1.88 mg (B/F/TAF 3.75/15/1.88 mg) administered orally as TOS, 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 adult strength B/F/TAF FDC, low dose B/F/TAF FDC, or B/F/TAF FDC TOS (based on age and weight) 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

Drug: B/F/TAF (TOS)
2 x FDC of bictegravir 15 mg/emtricitabine 60 mg/ tenofovir alafenamide 7.5 mg (B/F/TAF 15/60/7.5 mg) (total dose 30/120/15 mg) administered orally as TOS, once daily without regard to food
Other Name: GS-9883/F/TAF

Drug: B/F/TAF (TOS)
FDC of bictegravir 15 mg/emtricitabine 60 mg/ tenofovir alafenamide 7.5 mg (B/F/TAF 15/60/7.5 mg) administered orally as TOS, once daily without regard to food
Other Name: GS-9883/F/TAF

Drug: B/F/TAF (TOS)
2 x FDC of bictegravir 3.75 mg/emtricitabine 15 mg/ tenofovir alafenamide 1.88 mg (B/F/TAF 3.75/15/1.88 mg) (total dose 7.5/30/3.75 mg) administered orally as TOS, once daily without regard to food
Other Name: GS-9883/F/TAF

Drug: B/F/TAF (TOS)
FDC of bictegravir 3.75 mg/emtricitabine 15 mg/ tenofovir alafenamide 1.88 mg (B/F/TAF 3.75/15/1.88 mg) administered orally as TOS, 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 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  2. PK Parameter: Ctau of Bictegravir [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  3. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 24 [ Time Frame: Up to 24 weeks ]
  4. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24 [ Time Frame: Up to 24 weeks ]
  5. PK Parameter: AUClast of TAF (Cohort 4) [ Time Frame: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  6. PK Parameter: Cmax of TAF (Cohort 4) [ Time Frame: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]
    Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


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 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    Tmax is defined as the time (observed time point) of Cmax. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  8. PK Parameter: Cmax of Bictegravir [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    Cmax is defined as the maximum observed concentration of drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  9. PK Parameter: AUClast of Bictegravir [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    AUClast is defined as the area under the concentration of drug from time zero to the last observable concentration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  10. PK Parameter: T1/2 of Bictegravir [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    T1/2 is defined as the estimate of the terminal elimination half-life of the drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  11. PK Parameter: Apparent Clearance (CL) of Bictegravir [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    CL is defined as the systemic clearance of the drug following study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  12. PK Parameter: Apparent Vz of Bictegravir [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    Vz is defined as the volume of distribution of the drug after study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  13. PK Parameter: AUCtau of TAF and FTC [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  14. PK Parameter: AUClast of TAF and FTC (Cohorts 1, 2, and 3) [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose ]

    AUClast is defined as the area under the concentration of drug from time zero to the last observable concentration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.


  15. PK Parameter: AUClast of FTC (Cohorts 4) [ Time Frame: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  16. PK Parameter: Cmax of TAF and FTC (Cohorts 1, 2, and 3) [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose ]

    Cmax is defined as the maximum observed concentration of drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.


  17. PK Parameter: Cmax of FTC (Cohorts 4) [ Time Frame: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]
    Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

  18. PK Parameter: Ctau of TAF and FTC [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  19. PK Parameter: Tmax of TAF and FTC [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    Tmax is defined as the time (observed time point) of Cmax. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  20. PK Parameter: T1/2 of TAF and FTC [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    T1/2 is defined as the estimate of the terminal elimination half-life of the drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  21. PK Parameter: Apparent CL of TAF and FTC [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    CL is defined as the systemic clearance of the drug following study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  22. PK Parameter: Apparent Vz of TAF and FTC [ Time Frame: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose ]

    Vz is defined as the volume of distribution of the drug after study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.

    Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

    Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.


  23. Percentage of Participants Experiencing Treatment-Emergent Adverse Events Through Week 48 [ Time Frame: Up to 48 weeks ]
  24. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48 [ Time Frame: Up to 48 weeks ]
  25. Acceptability of B/F/TAF Formulation at Day 1 (All Cohorts) [ Time Frame: Day 1 ]

    Participants or legal guardian will be asked:

    • if study drug shape and size were acceptable (for Cohort 1 and Cohort 2)
    • about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3)
    • about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)

  26. Palatability of B/F/TAF Formulation at Day 1 (All Cohorts) [ Time Frame: Day 1 ]
    Participants or legal guardian will be asked about the study drug taste (All Cohorts)

  27. Acceptability of B/F/TAF Formulation at Week 4 (All Cohorts) [ Time Frame: Week 4 ]

    Participants or legal guardian will be asked:

    • if study drug shape and size were acceptable (for Cohort 1 and Cohort 2)
    • about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3).
    • about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)

  28. Palatability of B/F/TAF Formulation at Week 4 (All Cohorts) [ Time Frame: Week 4 ]
    Participants or legal guardian will be asked about the study drug taste (All Cohorts)

  29. Acceptability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4) [ Time Frame: Week 24 ]

    Participants or legal guardian will be asked:

    • about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3).
    • about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)

  30. Palatability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4) [ Time Frame: Week 24 ]
    Participants or legal guardian will be asked about the study drug taste

  31. Acceptability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4) [ Time Frame: Week 48 ]

    Participants or legal guardian will be asked:

    • about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3).
    • about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)

  32. Palatability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4) [ Time Frame: Week 48 ]
    Participants or legal guardian will be asked about the study drug taste

  33. Acceptability of B/F/TAF Formulation at Week 1 (Cohort 4) [ Time Frame: Week 1 ]
    Participants or legal guardian will be asked about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste

  34. Palatability of B/F/TAF Formulation at Week 1 (Cohort 4) [ Time Frame: Week 1 ]
    Participants or legal guardian will be asked about the study drug taste

  35. Acceptability of B/F/TAF Formulation at Week 2 (Cohort 4) [ Time Frame: Week 2 ]
    Participants or legal guardian will be asked about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste

  36. Palatability of B/F/TAF Formulation at Week 2 (Cohort 4) [ Time Frame: Week 2 ]
    Participants or legal guardian will be asked about the study drug taste



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Month 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.

Cohort 4 Group 1: 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 and unable to swallow tablets.

  • 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

Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to < 14 kg) who are treatment naive or on ARV treatment for ≥ 1 month prior to screening

  • Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age)
  • On a stable ARV regimen for ≥ 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment)
  • For < 1 year of age, eGFR ≥ the minimum normal values for age according to the information below using the Schwartz Formula

    • 30 mL/min/1.73 m^2 for age > 2 months to ≤ 95 days
    • 39 mL/min/1.73 m^2 for age ≥ 96 days to ≤ 6 months
    • 49 mL/min/1.73 m^2 for age > 6 months to < 12 months
  • For ≥ 1 year of age, eGFR ≥ 90 mL/min/1.73 m^2 using the Schwartz Formula
  • No documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. For individuals < 14 kg, M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed. Individuals with HIV-1 RNA > 50 copies/mL should not have FTC, TFV, or INSTI resistance mutations.
  • Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrollment

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


Locations
Show Show 22 study locations
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    
Other Study ID Numbers: GS-US-380-1474
2016-002345-39 ( EudraCT Number )
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020

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