The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed pregnant women in their second and third trimesters.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
50/200/25 mg FDC tablet administered orally once daily without regard to food.
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Instituto Dominicano de Estudios Virologics (IDEV)
Santo Domingo, Dominican Republic
Faculty of Medicine Siriraj Hospital
Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC)
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
PK Parameter: AUClast of BIC, FTC, and TAF
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
PK Parameter: Cmax of BIC, FTC, and TAF
Cmax is defined as the maximum observed concentration of drug during the dosing interval.
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
PK Parameter: Ctau of BIC and FTC
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
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Bangkok Noi, Thailand
Faculty of Medicine-Khon Kaen University
Khon Kaen, Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand
Research Institute for Health Sciences, Chiang Mai University
Nonthaburi, Thailand
Thai Red Cross AIDS Research Centre
Pathumwan, Thailand
PK Parameter: Clast of BIC, FTC, and TAF
Clast is defined as the last observable concentration of drug.
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
PK Parameter: Tmax of BIC, FTC, and TAF
Tmax is defined as the time (observed time point) of Cmax.
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
PK Parameter: t1/2 of BIC, FTC, and TAF
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
PK Parameter: CLss/F of BIC, FTC, and TAF
CLss/F is defined as the apparent steady-state oral clearance following administration of the drug.
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
PK Parameter: Vz/F of BIC, FTC, and TAF
Vz/F is defined as the apparent volume of distribution of the drug.
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
PK Parameter: λz of BIC, FTC, and TAF
λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
Time frame: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at the Time of Delivery Using the Missing = Excluded Approach in B/F/TAF Group
The percentage of participants with HIV-1 RNA \< 50 copies/mL at the time of delivery was analyzed in B/F/TAF group 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).
Time frame: At time of delivery
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Birth Using the Missing = Excluded Approach in Neonates
The percentage of participants with HIV-1 RNA \< 50 copies/mL at the time of birth was analyzed in neonates 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).
Time frame: At birth