HIV-1-infection
Conditions
Brief summary
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.
Interventions
DRUGB/F/TAF
Tablet for oral suspension administered
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Mother inclusion criteria: * Be on standard of care (SOC) antiretroviral therapy for human immunodeficiency virus type 1 (HIV-1) treatment. * Have confirmed HIV-1 infection based on positive test results obtained from medical records. Neonate inclusion criteria: * Be born at term (≥ 37.0 weeks gestational age). * Be able to take oral medication. * Be ≤ 120 hours of life at enrollment. * Have a birth weight ≥ 2.5 kg. * Is receiving or plans to receive HIV-1 SOC prophylaxis regimen with 1 antiretroviral (ARV) to prevent perinatal transmission. Key
Exclusion criteria
Mother
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters for BIC: Cmin | Predose up to 72 hours postdose | Cmin is defined as the minimum observed concentration of drug. |
| PK parameters for BIC: C24h | At 24 hours postdose | C24h is defined as the concentration of drug at time 24 hours. |
| PK parameters for BIC: t1/2 | Predose up to 72 hours postdose | t1/2 is defined as the terminal elimination half-life. |
| PK parameters for BIC: Apparent CL/F | Predose up to 72 hours postdose | Apparent CL/F is defined as the apparent total body clearance for extravascular administration. |
| PK parameters for BIC: Apparent Vz/F | Predose up to 72 hours postdose | Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase. |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth | First dose date up to 8 Weeks | — |
| Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth | First dose date up to 8 Weeks | — |
| Pharmacokinetic (PK) parameters for Bictegravir (BIC): AUCinf | Predose up to 72 hours postdose | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time. |
| PK parameters for BIC: AUClast | Predose up to 72 hours postdose | AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration. |
| PK parameters for BIC: AUC0-24h | Predose up to 24 hours postdose | AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours. |
| PK parameters for BIC: Cmax | Predose up to 72 hours postdose | Cmax is defined as the maximum observed concentration of drug. |
| PK parameters for BIC: Tmax | Predose up to 72 hours postdose | Tmax is defined as the time (observed time point) of Cmax. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters for FTC, TAF, and TFV: C24h | At 24 hours postdose | C24h is defined as the concentration of drug at time 24 hours. |
| PK parameters for FTC and TAF: Apparent Vz/F | Predose up to 72 hours postdose | Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase. |
| Mother/Caregiver Reported Acceptability of B/F/TAF tablet for oral suspension (TOS) | First dose date up to 15 days | Acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better acceptability. |
| Mother/Caregiver Reported Palatability of B/F/TAF tablet for oral suspension (TOS) | First dose date up to 15 days | Palatability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability. |
| PK parameters for FTC, TAF, and TFV: t1/2 | Predose up to 72 hours postdose | t1/2 is defined as the terminal elimination half-life. |
| PK Parameters for Emtricitabine (FTC), and Tenofovir (TFV): AUCinf | Predose up to 72 hours postdose | AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time. |
| PK parameters for FTC, TAF, and TFV: AUClast | Predose up to 72 hours postdose | AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration. |
| PK parameters for FTC, TAF, and TFV: AUC0-24h | Predose up to 24 hours postdose | AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours. |
| PK parameters for FTC, TAF, and TFV: Cmax | Predose up to 72 hours postdose | Cmax is defined as the maximum observed concentration of drug. |
| PK parameters for FTC, TAF, and TFV: Tmax | Predose up to 72 hours postdose | Tmax is defined as the time (observed time point) of Cmax. |
| PK parameters for FTC, TAF, and TFV: Cmin | Predose up to 72 hours postdose | Cmin is defined as the minimum observed concentration of drug. |
| PK parameters for FTC and TAF: Apparent CL/F | Predose up to 72 hours postdose | Apparent CL/F is defined as the apparent total body clearance for extravascular administration. |
Countries
South Africa, United States
Contacts
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed