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Report for Clinical Trial NCT03960645

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1b, Open-label Study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

The primary objective of this study is to evaluate the steady state pharmacokinetics 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.

NCT03960645 HIV-1-infection

1 Interventions

Name: B/F/TAF

Description: 50/200/25 mg FDC tablet administered orally once daily without regard to food
Type: Drug
Group Labels: 1

B/F/TAF


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: Pharmacokinetic (PK) Parameter: AUCtau of BIC

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Secondary 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 emtricitabine (FTC) and tenofovir alafenamide (TAF)

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

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

Measure: PK Parameter: AUClast of BIC, FTC, and TAF

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

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

Measure: PK Parameter: Cmax of BIC, FTC, and TAF

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

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

Measure: PK Parameter: Ctau of BIC and FTC

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Description: Clast is defined as the last observable concentration of drug.

Measure: PK Parameter: Clast of BIC, FTC, and TAF

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

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

Measure: PK Parameter: Tmax of BIC, FTC, and TAF

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Description: t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Measure: PK Parameter: t1/2 of BIC, FTC, and TAF

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Description: CL/F is defined as the apparent oral clearance following administration of the drug.

Measure: PK Parameter: CL/F of BIC, FTC, and TAF

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Description: Vz/F is defined as the apparent volume of distribution of the drug.

Measure: PK Parameter: Vz/F of BIC, FTC, and TAF

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Description: 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.

Measure: PK Parameter: λz of BIC, FTC, and TAF

Time: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Measure: Proportion of Participants With HIV-1 RNA < 50 Copies/mL Using the Missing = Excluded Approach

Time: At the Time of Delivery

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 K65R

Key Inclusion Criteria: - The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - With singleton pregnancy, at least 12 weeks but not more than 31 weeks pregnant at the time of screening - Agree not to breastfeed for the duration of the study - Currently on a stable antiretroviral regimen for ≥ 6 months preceding the screening visit - Documented plasma HIV-1 RNA levels of < 50 copies/mL for ≥ 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at the screening visit - Have no documented or suspected resistance to FTC, Tenofovir (TFV), or integrase strand-transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R or M184V/I - Historic genotype reports will be collected if available - Have a normal ultrasound, completed locally prior to the Day 1 visit, with no evidence of any fetal malformation or structural abnormality affecting either fetus or placenta - Normal maternal alfa-fetoprotein level at the screening visit Key Exclusion Criteria: - Have chronic hepatitis B virus (HBV) - Have active hepatitis C virus (HCV) infection - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening Note: Other protocol defined Inclusion/Exclusion criteria may apply. --- K65R ---


2 M184V

Key Inclusion Criteria: - The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - With singleton pregnancy, at least 12 weeks but not more than 31 weeks pregnant at the time of screening - Agree not to breastfeed for the duration of the study - Currently on a stable antiretroviral regimen for ≥ 6 months preceding the screening visit - Documented plasma HIV-1 RNA levels of < 50 copies/mL for ≥ 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at the screening visit - Have no documented or suspected resistance to FTC, Tenofovir (TFV), or integrase strand-transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R or M184V/I - Historic genotype reports will be collected if available - Have a normal ultrasound, completed locally prior to the Day 1 visit, with no evidence of any fetal malformation or structural abnormality affecting either fetus or placenta - Normal maternal alfa-fetoprotein level at the screening visit Key Exclusion Criteria: - Have chronic hepatitis B virus (HBV) - Have active hepatitis C virus (HCV) infection - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening Note: Other protocol defined Inclusion/Exclusion criteria may apply. --- K65R --- --- M184V ---



HPO Nodes