The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) in neonates exposed to human immunodeficiency virus type 1 (HIV-1). The primary objective of this study is to evaluate the safety and plasma pharmacokinetics (PK) (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) of B/F/TAF tablet for oral suspension (TOS) in full-term neonates exposed to HIV-1 but uninfected.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Tablet for oral suspension administered
Ronald Reagan UCLA Medical Center (inpatient hospital)
Los Angeles, California, United States
Grady Health System - Ponce de Leon Center
Atlanta, Georgia, United States
St Jude Children's Research Hospital
Memphis, Tennessee, United States
Family Centre for Research with Ubuntu (FAMCRU)
Cape Town, South Africa
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, South Africa
Perinatal HIV Research Unit (PHRU)
Gauteng, South Africa
WITS RHI Shandukani Research Centre
Johannesburg, South Africa
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth
Time frame: First dose date up to 8 Weeks
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth
Time frame: First dose date up to 8 Weeks
Pharmacokinetic (PK) parameters for Bictegravir (BIC): AUCinf
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
Time frame: Predose up to 72 hours postdose
PK parameters for BIC: AUClast
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
Time frame: Predose up to 72 hours postdose
PK parameters for BIC: AUC0-24h
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
Time frame: Predose up to 24 hours postdose
PK parameters for BIC: Cmax
Cmax is defined as the maximum observed concentration of drug.
Time frame: Predose up to 72 hours postdose
PK parameters for BIC: Tmax
Tmax is defined as the time (observed time point) of Cmax.
Time frame: Predose up to 72 hours postdose
PK parameters for BIC: Cmin
Cmin is defined as the minimum observed concentration of drug.
Time frame: Predose up to 72 hours postdose
PK parameters for BIC: C24h
C24h is defined as the concentration of drug at time 24 hours.
Time frame: At 24 hours postdose
PK parameters for BIC: t1/2
t1/2 is defined as the terminal elimination half-life.
Time frame: Predose up to 72 hours postdose
PK parameters for BIC: Apparent CL/F
Apparent CL/F is defined as the apparent total body clearance for extravascular administration.
Time frame: Predose up to 72 hours postdose
PK parameters for BIC: Apparent Vz/F
Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.
Time frame: Predose up to 72 hours postdose
PK Parameters for Emtricitabine (FTC), and Tenofovir (TFV): AUCinf
AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time.
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: AUClast
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: AUC0-24h
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
Time frame: Predose up to 24 hours postdose
PK parameters for FTC, TAF, and TFV: Cmax
Cmax is defined as the maximum observed concentration of drug.
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: Tmax
Tmax is defined as the time (observed time point) of Cmax.
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: Cmin
Cmin is defined as the minimum observed concentration of drug.
Time frame: Predose up to 72 hours postdose
PK parameters for FTC, TAF, and TFV: C24h
C24h is defined as the concentration of drug at time 24 hours.
Time frame: At 24 hours postdose
PK parameters for FTC, TAF, and TFV: t1/2
t1/2 is defined as the terminal elimination half-life.
Time frame: Predose up to 72 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK parameters for FTC and TAF: Apparent CL/F
Apparent CL/F is defined as the apparent total body clearance for extravascular administration.
Time frame: Predose up to 72 hours postdose
PK parameters for FTC and TAF: Apparent Vz/F
Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.
Time frame: Predose up to 72 hours postdose
Mother/Caregiver Reported Acceptability of B/F/TAF tablet for oral suspension (TOS)
Acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better acceptability.
Time frame: First dose date up to 15 days
Mother/Caregiver Reported Palatability of B/F/TAF tablet for oral suspension (TOS)
Palatability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability.
Time frame: First dose date up to 15 days