B/F/TAF (Adult Strength): 50/200/25 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (Low Dose): 30/120/15 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (TOS): 2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily.
B/F/TAF (TOS): 2 x B/F/TAF 3.75/15/1.88 mg (total daily dose 15/60/7.52 mg) FDC tablets administered orally as TOS, twice daily.
B/F/TAF (TOS): 1 x B/F/TAF 3.75/15/1.88 mg (total daily dose 7.5/30/3.76 mg) FDC tablets administered orally as TOS, twice daily.
B/F/TAF (TOS): 1 x B/F/TAF 1.88/7.5/0.94 mg (total daily dose 3.76/15/1.88 mg) FDC tablets administered orally as TOS, twice daily
Study summary
The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.
Eligibility
Sex
ALL
Min age
1 Month
Max age
17 Years
Healthy volunteers
No
Key Inclusion Criteria:
Cohort 1: HIV-1 infected adolescents (12 to \< 18 years of age and screening weight ≥ 35 kg) who are virologically suppressed for ≥ 6 months prior to screening. Cohort 2: HIV-1 infected children (6 to \< 12 years of age and screening weight ≥ 25 kg) who are virologically suppressed for ≥ 6 months prior to screening.
Cohort 3: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to \< 25 kg) who are virologically suppressed for ≥ 6 months prior to screening.
Cohort 4 Group 1: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to \< 25 kg) who are virologically suppressed for ≥ 6 months prior to screening and unable to swallow tablets.
* Documented plasma HIV-1 ribonucleic acid (RNA) \< 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the Screening visit. Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is \< 50 copies/mL (eg, \< 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests.
* Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen.
* Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m\^2 according to the Schwartz Formula.
* No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I.
Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to \< 14 kg) who are treatment naive or on antiretroviral (ARV) treatment for ≥ 1 month prior to screening.
* Positive confirmatory HIV test (confirmatory nucleic acid-based testing if \< 18 months of age).
* On a stable ARV regimen for ≥ 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment).
* For \< 1 year of age, eGFR ≥ the minimum normal values for age according to the information below using the Schwartz Formula,
* 30 mL/min/1.73 m\^2 for age \> 4 weeks to ≤ 95 days.
* 39 mL/min/1.73 m\^2 for age ≥ 96 days to ≤ 6 months.
* 49 mL/min/1.73 m\^2 for age \> 6 months to \< 12 months.
* For ≥ 1 year of age, eGFR ≥ 90 mL/min/1.73 m\^2 using the Schwartz Formula.
* No documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R.
* For individuals \< 14 kg, M184V/I AND HIV-1 RNA \< 50 copies/mL will be allowed. Individuals with HIV-1 RNA \> 50 copies/mL should not have FTC, TFV, or INSTI resistance mutations.
* Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrollment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
PK Parameter: AUCtau of Bictegravir — Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 \& 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
PK Parameter: Ctau of Bictegravir — Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 \& 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
PK Parameter: AUC0-24 of TAF (Cohort 4) — Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
PK Parameter: AUC0-24 of Bictegravir (Cohort 4) — Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
PK Parameter: Cmax of TAF (Cohort 4) — Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 24 — Up to 24 weeks
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24 — Up to 24 weeks
Trial sites (25)
Facility
City
Region
Status
Children's National Health System
Washington D.C.
District of Columbia
Midway Immunology and Research Center
Ft. Pierce
Florida
University of Florida Health
Gainesville
Florida
USF Clinic at Children's Medical Services (study visits and drug storage)
Tampa
Florida
Grady Health System Ponce Center Family and Youth Clinic
Atlanta
Georgia
Wayne Pediatric Clinic
Detroit
Michigan
Bellevue Hospital
New York
New York
Duke Children's Health Center, Pediatric Infectious Diseases
Durham
North Carolina
St. Christopher's Hospital for Children/Section of Immunology
Philadelphia
Pennsylvania
St. Jude Children's Research Hospital
Memphis
Tennessee
Department of Paediatrics and Child Health
Bloemfontein
South Africa
Be Part Ypluntu Centre
Cape Town
South Africa
FAMCRU, Ward J8
CapeTown
South Africa
Dr. J Fourie Medical Centre
Dundee
South Africa
Enhancing Care Foundation, Durban International Clinical Research Site
Durban
South Africa
Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute
Johannesburg
South Africa
Empilweni Service and Research Unit (ESRU)
Johannesburg
South Africa
VX Pharma(Pty) Ltd
Pretoria
South Africa
Perinatal HIV Research Unit
Soweto
South Africa
The HIV Netherlands Australia Thailand Research Collaboration
Bangkok
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok
Thailand
Faculty of Medicine, Khon Kaen University
Khon Kaen
Thailand
Makerere University, Johns Hopkins (MU-JHU) Research Collaboration
Kampala
Uganda
Joint Clinical Research Centre
Kampala
Uganda
Baylor College of Medicine Children's Foundation - Uganda
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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