Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03110380 | Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed | PHASE3 | COMPLETED | 567 | — | — | Jun 12, 2017 | Feb 10, 2021 | Jan 11, 2022 | 94 | United States, Austria +4 |
| NCT07055451 | Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV | PHASE1 | ACTIVE NOT_RECRUITING | 16 | — | — | Aug 12, 2025 | Mar 1, 2028 | Apr 15, 2026 | 7 | United States, South Africa |
| NCT03960645 | Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters | PHASE1 | COMPLETED | 62 | — | — | Jun 28, 2019 | Aug 18, 2022 | Jun 14, 2024 | 8 | United States, Dominican Republic +1 |
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
Cmax is defined as the maximum observed concentration of drug.
Tmax is defined as the time (observed time point) of Cmax.
Cmin is defined as the minimum observed concentration of drug.
C24h is defined as the concentration of drug at time 24 hours.
t1/2 is defined as the terminal elimination half-life.
Apparent CL/F is defined as the apparent total body clearance for extravascular administration.
Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
| Arm | Type | Description |
|---|---|---|
| B/F/TAF | EXPERIMENTAL | Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks. |
| DTG + F/TAF | ACTIVE_COMPARATOR | DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks. |
| Open-label Phase B/F/TAF from B/F/TAF | EXPERIMENTAL | Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. |
| Open-label Phase B/F/TAF from DTG + F/TAF | EXPERIMENTAL | Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. |
| 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. |
| 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. |
| Neonates | NO_INTERVENTION | Neonates who will be born to women participants in the study will be followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates that participate in the study will be treated with the study drug. |
| Name | Type | Description |
|---|---|---|
| B/F/TAF | DRUG | 50/200/25 mg FDC tablet(s) administered orally once daily |
| F/TAF | DRUG | 200/25 mg FDC tablet(s) administered orally once daily |
| DTG | DRUG | 50 mg tablet(s) administered orally once daily |
| DTG Placebo | DRUG | Tablet(s) administered orally once daily |
| F/TAF Placebo | DRUG | Tablet(s) administered orally once daily |
| B/F/TAF Placebo | DRUG | Tablet(s) administered orally once daily |
Key Inclusion Criteria: * Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods: * ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance prior to the screening visit) * ≥ 3 months (i...