Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
NCT ID: NCT02881320
Last Updated: 2026-02-17
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
177 participants
INTERVENTIONAL
2016-09-21
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg)
* Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48.
* Part B: Following confirmation of BIC PK data from Cohort 1 Part A, participants will receive the adult strength B/F/TAF through Week 48.
B/F/TAF (Adult Strength)
50/200/25 mg FDC tablets administered orally once daily without regard to food.
Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg)
* Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48.
* Part B: Following confirmation of BIC PK data from Cohort 2 Part A, participants will receive the adult strength B/F/TAF FDC through Week 48.
B/F/TAF (Adult Strength)
50/200/25 mg FDC tablets administered orally once daily without regard to food.
Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg)
* Part A: Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive the low dose B/F/TAF FDC tablet through Week 48.
* Part B: Following confirmation of BIC PK data from Cohort 3 Part A, participants will receive the low dose B/F/TAF FDC tablet through Week 48.
B/F/TAF (Low Dose)
30/120/15 mg FDC tablets administered orally once daily without regard to food.
Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg)
Due to Cohort 3 Part A Intensive PK evaluation at Week 2 with the low dose B/F/TAF FDC tablet, participants will not participate in an Intensive PK evaluation at Week 2.
Participants will receive B/F/TAF FDC tablets for oral suspension (TOS) once daily through Week 48.
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.
Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg)
Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.
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.
Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg)
Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.
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.
Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg)
Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.
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
Open-Label Extension
Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive adult strength B/F/TAF FDC, low dose B/F/TAF FDC, or B/F/TAF FDC TOS (based on age and weight) until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
1 Month
17 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Children's National Health System
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
University of Florida Health
Gainesville, Florida, United States
USF Clinic at Children's Medical Services (study visits and drug storage)
Tampa, Florida, United States
Grady Health System Ponce Center Family and Youth Clinic
Atlanta, Georgia, United States
Wayne Pediatric Clinic
Detroit, Michigan, United States
Bellevue Hospital
New York, New York, United States
Duke Children's Health Center, Pediatric Infectious Diseases
Durham, North Carolina, United States
St. Christopher's Hospital for Children/Section of Immunology
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
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
Kampala, , Uganda
Countries
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References
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Rodriguez CA, Natukunda E, Strehlau R, Venter EL, Rungmaitree S, Cunningham CK, Lalloo U, Kosalaraksa P, HellstrOm E, Liberty A, McGrath EJ, Kaur M, Leisegang R, Hindman JT, Vieira VA, Kersey K, Cotton MF, Rakhmanina N, Gaur AH. Pharmacokinetics and safety of coformulated bictegravir, emtricitabine, and tenofovir alafenamide in children aged 2 years and older with virologically suppressed HIV: a phase 2/3, open-label, single-arm study. Lancet HIV. 2024 May;11(5):e300-e308. doi: 10.1016/S2352-3018(23)00327-2. Epub 2024 Apr 12.
Gaur AH, Cotton MF, Rodriguez CA, McGrath EJ, Helstrom E, Liberty A, Natukunda E, Kosalaraksa P, Chokephaibulkit K, Maxwell H, Wong P, Porter D, Majeed S, Yue MS, Graham H, Martin H, Brainard DM, Pikora C. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide in adolescents and children with HIV: week 48 results of a single-arm, open-label, multicentre, phase 2/3 trial. Lancet Child Adolesc Health. 2021 Sep;5(9):642-651. doi: 10.1016/S2352-4642(21)00165-6. Epub 2021 Jul 22.
Other Identifiers
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2016-002345-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-380-1474
Identifier Type: -
Identifier Source: org_study_id
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