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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Group A of B/F/TAF | Experimental | Full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group A to evaluate a different pharmacokinetic (PK) sampling scheme than Cohort 1 Group B. Neonate participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. |
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| Cohort 1: Group B of B/F/TAF | Experimental | Once enrollment in Cohort 1 Group A is completed, full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group B to evaluate a different PK sampling scheme than Cohort 1 Group A. Participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/F/TAF | Drug | Tablet for oral suspension administered |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time. | 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. | 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. | Predose up to 24 hours postdose |
| PK parameters for BIC: Cmax | Cmax is defined as the maximum observed concentration of drug. | Predose up to 72 hours postdose |
| PK parameters for BIC: Tmax | Tmax is defined as the time (observed time point) of Cmax. | Predose up to 72 hours postdose |
| PK parameters for BIC: Cmin |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose up to 72 hours postdose |
| PK parameters for FTC, TAF, and TFV: AUClast |
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Key Inclusion Criteria:
Mother inclusion criteria:
Neonate inclusion criteria:
Key Exclusion Criteria:
Mother exclusion criteria:
Neonate exclusion criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center (inpatient hospital) | Los Angeles | California | 90095 | United States | ||
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Cmin is defined as the minimum observed concentration of drug. |
| Predose up to 72 hours postdose |
| PK parameters for BIC: C24h | C24h is defined as the concentration of drug at time 24 hours. | At 24 hours postdose |
| PK parameters for BIC: t1/2 | t1/2 is defined as the terminal elimination half-life. | 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. | 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. | 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.
| 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. | Predose up to 24 hours postdose |
| PK parameters for FTC, TAF, and TFV: Cmax | Cmax is defined as the maximum observed concentration of drug. | 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. | Predose up to 72 hours postdose |
| PK parameters for FTC, TAF, and TFV: Cmin | Cmin is defined as the minimum observed concentration of drug. | 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. | At 24 hours postdose |
| PK parameters for FTC, TAF, and TFV: t1/2 | t1/2 is defined as the terminal elimination half-life. | Predose up to 72 hours postdose |
| PK parameters for FTC and TAF: Apparent CL/F | Apparent CL/F is defined as the apparent total body clearance for extravascular administration. | 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. | 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. | 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. | First dose date up to 15 days |
| Grady Health System - Ponce de Leon Center |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| St Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Family Centre for Research with Ubuntu (FAMCRU) | Cape Town | 7505 | South Africa |
| Durban International Clinical Research Site, Enhancing Care Foundation | Durban | 4013 | South Africa |
| Perinatal HIV Research Unit (PHRU) | Gauteng | 1864 | South Africa |
| WITS RHI Shandukani Research Centre | Johannesburg | 2001 | South Africa |