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Report for Clinical Trial NCT02881320

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT02881320 HIV-1 Infection

2 Interventions

Name: B/F/TAF (Adult Strength)

Description: 50/200/25 mg FDC tablets administered orally once daily without regard to food
Type: Drug
Group Labels: 7

Cohort 1 (12 to Cohort 1 (12 to < Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg) Cohort 2 (6 to Cohort 2 (6 to < Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg) Open-Label Extension

Name: B/F/TAF (Low Dose)

Description: 30/120/15 mg FDC tablets administered orally once daily without regard to food
Type: Drug
Group Labels: 4

Cohort 3 (≥ 2 years of age and weight ≥ 14 to Cohort 3 (≥ 2 years of age and weight ≥ 14 to < Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg) Open-Label Extension


Primary Outcomes

Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Measure: PK Parameter: AUCtau of Bictegravir

Time: Week 2 (all Cohorts) or Week 4 (Cohort 1 and Cohort 2 Part A participants only)

Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.

Measure: PK Parameter: Ctau of Bictegravir

Time: Week 2 (all Cohorts) or Week 4 (Cohort 1 and Cohort 2 Part A participants only)

Measure: Incidence of Treatment-Emergent Adverse Events (AEs) Through Week 24

Time: Up to 24 weeks

Measure: Incidence of Treatment-Emergent Laboratory Abnormalities Through Week 24

Time: Up to 24 weeks

Secondary Outcomes

Measure: Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm

Time: Week 24

Measure: Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

Time: Week 48

Measure: Change from Baseline in CD4+ Cell Counts at Week 24

Time: Week 24

Measure: Change from Baseline in CD4+ Cell Counts at Week 48

Time: Week 48

Measure: Change from Baseline in CD4+ Cell Count Percentages at Week 24

Time: Week 24

Measure: Change from Baseline in CD4+ Cell Count Percentages at Week 48

Time: Week 48

Description: Tmax is defined as the time (observed time point) of Cmax.

Measure: PK Parameter: Tmax of Bictegravir

Time: Week 2 or Week 4

Description: Cmax is defined as the maximum observed concentration of drug.

Measure: PK Parameter: Cmax of Bictegravir

Time: Week 2 or Week 4

Description: AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Measure: PK Parameter: AUClast of Bictegravir

Time: Week 2 or Week 4

Description: T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Measure: PK Parameter: T1/2 of Bictegravir

Time: Week 2 or Week 4

Description: CL is defined as the systemic clearance of the drug following study drug administration.

Measure: PK Parameter: Apparent Clearance (CL) of Bictegravir

Time: Week 2 or Week 4

Description: Vz is defined as the volume of distribution of the drug after study drug administration.

Measure: PK Parameter: Apparent Vz of Bictegravir

Time: Week 2 or Week 4

Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Measure: PK Parameter: AUCtau of TAF and FTC

Time: Week 2 or Week 4

Description: AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Measure: PK Parameter: AUClast of TAF and FTC

Time: Week 2 or Week 4

Description: Cmax is defined as the maximum observed concentration of drug.

Measure: PK Parameter: Cmax of TAF and FTC

Time: Week 2 or Week 4

Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.

Measure: PK Parameter: Ctau of TAF and FTC

Time: Week 2 or Week 4

Description: Tmax is defined as the time (observed time point) of Cmax.

Measure: PK Parameter: Tmax of TAF and FTC

Time: Week 2 or Week 4

Description: T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Measure: PK Parameter: T1/2 of TAF and FTC

Time: Week 2 or Week 4

Description: CL is defined as the systemic clearance of the drug following study drug administration.

Measure: PK Parameter: Apparent CL of TAF and FTC

Time: Week 2 or Week 4

Description: Vz is defined as the volume of distribution of the drug after study drug administration.

Measure: PK Parameter: Apparent Vz of TAF and FTC

Time: Week 2 or Week 4

Measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events Through the Study

Time: Up to 48 weeks

Measure: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through the Study

Time: Up to 48 weeks

Description: Participants will be asked if the study drug was palatable and if they were able to take the dosage form.

Measure: Acceptability and Palatability of B/F/TAF Formulation at Day 1 (All Cohorts)

Time: Day 1

Description: Participants will be asked if the study drug was palatable and if they were able to take the dosage form.

Measure: Acceptability and Palatability of B/F/TAF Formulation at Week 4 (All Cohorts)

Time: Week 4

Description: Participants will be asked if the study drug was palatable and if they were able to take the dosage form.

Measure: Acceptability and Palatability of B/F/TAF Formulation at Week 24 (Cohort 3)

Time: Week 24

Description: Participants will be asked if the study drug was palatable and if they were able to take the dosage form.

Measure: Acceptability and Palatability of B/F/TAF Formulation at Week 48 (Cohort 3)

Time: Week 48

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 2 SNPs

SNPs


1 K65R

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. --- K65R ---


2 M184V

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. --- K65R --- --- M184V ---



HPO Nodes