HIV-1 InfectionPhase 2/3NCT02881320
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
A Phase 2/3 study testing B/F/TAF (Adult Strength), B/F/TAF (Low Dose) and B/F/TAF (TOS) in people with HIV-1 Infection, run by Gilead Sciences at 25 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- B/F/TAF (Adult Strength), B/F/TAF (Low Dose) and B/F/TAF (TOS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 21 Sep 2016to Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States10 sites
Grady Health System Ponce Center Family and Youth Clinic
Atlanta, Georgia, 30322
Wayne Pediatric Clinic
Detroit, Michigan, 48201
Duke Children's Health Center, Pediatric Infectious Diseases
Durham, North Carolina, 27710
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
University of Florida Health
Gainesville, Florida, 32209
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Bellevue Hospital
New York, New York, 10016
St. Christopher's Hospital for Children/Section of Immunology
Philadelphia, Pennsylvania, 19134
USF Clinic at Children's Medical Services (study visits and drug storage)
Tampa, Florida, 33606
Children's National Health System
Washington D.C., District of Columbia, 20010
South Africa9 sites
Department of Paediatrics and Child Health
Bloemfontein, 9301
Be Part Ypluntu Centre
Cape Town, 7646
FAMCRU, Ward J8
CapeTown, 7505
Dr. J Fourie Medical Centre
Dundee, 3000
Enhancing Care Foundation, Durban International Clinical Research Site
Durban, 4302
Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute
Johannesburg, 2038
Empilweni Service and Research Unit (ESRU)
Johannesburg, 2112
VX Pharma(Pty) Ltd
Pretoria, 0087
Perinatal HIV Research Unit
Soweto, 2013
Thailand3 sites
The HIV Netherlands Australia Thailand Research Collaboration
Bangkok, 10330
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Faculty of Medicine, Khon Kaen University
Khon Kaen, 40002
Uganda3 sites
Makerere University, Johns Hopkins (MU-JHU) Research Collaboration
Kampala, 0000
Joint Clinical Research Centre
Kampala, 10005
Baylor College of Medicine Children's Foundation - Uganda
Kampala
About this study
Official title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
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.
- Conditions
- HIV-1 Infection
- Being tested
- B/F/TAF (Adult Strength), B/F/TAF (Low Dose), B/F/TAF (TOS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAF (Adult Strength)Drug
Also called Biktarvy®, GS-9883/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (Low Dose)Drug
Also called GS-9883/F/TAF
30/120/15 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (TOS)Drug
Also called GS-9883/F/TAF
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)Drug
Also called GS-9883/F/TAF
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)Drug
Also called GS-9883/F/TAF
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)Drug
Also called GS-9883/F/TAF
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 group | Role | What they receive |
|---|---|---|
| Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg) | Experimental | * 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. Receives: Drug: B/F/TAF (Adult Strength) |
| Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg) | Experimental | * 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. Receives: Drug: B/F/TAF (Adult Strength) |
| Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg) | Experimental | * 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. Receives: Drug: B/F/TAF (Low Dose) |
| Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg) | Experimental | 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. Receives: Drug: B/F/TAF (TOS) |
| Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg) | Experimental | 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. Receives: Drug: B/F/TAF (TOS) |
| Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg) | Experimental | 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. Receives: Drug: B/F/TAF (TOS) |
| Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg) | Experimental | 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. Receives: Drug: B/F/TAF (TOS) |
| Open-Label Extension | Experimental | 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. Receives: Drug: B/F/TAF (Adult Strength); Drug: B/F/TAF (Low Dose); Drug: B/F/TAF (TOS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Parameter: AUCtau of Bictegravir
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.
Measured: 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
PK Parameter: Ctau of Bictegravir
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.
Measured: 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
PK Parameter: AUC0-24 of TAF (Cohort 4)
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.
Measured: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: AUC0-24 of Bictegravir (Cohort 4)
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.
Measured: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: Cmax of TAF (Cohort 4)
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.
Measured: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 24
Measured: Up to 24 weeks
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24
Measured: Up to 24 weeks
Secondary outcomes (36)
Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm
Measured: Week 24
Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Measured: Week 48
Change from Baseline in CD4+ Cell Counts at Week 24
Measured: Baseline, Week 24
Change from Baseline in CD4+ Cell Counts at Week 48
Measured: Baseline, Week 48
Change from Baseline in CD4+ Cell Count Percentages at Week 24
Measured: Baseline, Week 24
Change from Baseline in CD4+ Cell Count Percentages at Week 48
Measured: Baseline, Week 48
PK Parameter: Tmax of Bictegravir
Tmax is defined as the time (observed time point) of Cmax. 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.
Measured: 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
PK Parameter: Cmax of Bictegravir
Cmax is defined as the maximum observed concentration of drug. 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.
Measured: 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
PK Parameter: AUClast of Bictegravir
AUClast is defined as the area under the concentration of drug from time zero to the last observable concentration. 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.
Measured: 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
PK Parameter: T1/2 of Bictegravir
T1/2 is defined as the estimate of the terminal elimination half-life of the drug. 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.
Measured: 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
PK Parameter: Apparent Clearance (CL) of Bictegravir
CL is defined as the systemic clearance of the drug following study drug administration. 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.
Measured: 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
PK Parameter: Apparent Vz of Bictegravir
Vz is defined as the volume of distribution of the drug after study drug administration. 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.
Measured: 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
PK Parameter: AUCtau of TAF and FTC
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.
Measured: 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
PK Parameter: AUClast of TAF and FTC (Cohorts 1, 2, and 3)
AUClast is defined as the area under the concentration of drug from time zero to the last observable concentration. 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.
Measured: 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
PK Parameter: AUClast of FTC (Cohorts 4)
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.
Measured: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: Cmax of TAF and FTC (Cohorts 1, 2, and 3)
Cmax is defined as the maximum observed concentration of drug. 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.
Measured: 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
PK Parameter: Cmax of FTC (Cohorts 4)
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.
Measured: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: Ctau of TAF and FTC
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.
Measured: 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
PK Parameter: Tmax of TAF and FTC
Tmax is defined as the time (observed time point) of Cmax. 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.
Measured: 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
PK Parameter: T1/2 of TAF and FTC
T1/2 is defined as the estimate of the terminal elimination half-life of the drug. 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.
Measured: 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
PK Parameter: Apparent CL of TAF and FTC
CL is defined as the systemic clearance of the drug following study drug administration. 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.
Measured: 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
PK Parameter: Apparent Vz of TAF and FTC
Vz is defined as the volume of distribution of the drug after study drug administration. 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.
Measured: 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
Percentage of Participants Experiencing Treatment-Emergent Adverse Events Through Week 48
Measured: Up to 48 weeks
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48
Measured: Up to 48 weeks
Acceptability of B/F/TAF Formulation at Day 1 (All Cohorts)
Participants or legal guardian will be asked:
- if study drug shape and size were acceptable (for Cohort 1 and Cohort 2)
- about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3)
- about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)
Measured: Day 1
Palatability of B/F/TAF Formulation at Day 1 (All Cohorts)
Participants or legal guardian will be asked about the study drug taste (All Cohorts)
Measured: Day 1
Acceptability of B/F/TAF Formulation at Week 4 (All Cohorts)
Participants or legal guardian will be asked:
- if study drug shape and size were acceptable (for Cohort 1 and Cohort 2)
- about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3).
- about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)
Measured: Week 4
Palatability of B/F/TAF Formulation at Week 4 (All Cohorts)
Participants or legal guardian will be asked about the study drug taste (All Cohorts)
Measured: Week 4
Acceptability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)
Participants or legal guardian will be asked:
- about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3).
- about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)
Measured: Week 24
Palatability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)
Participants or legal guardian will be asked about the study drug taste
Measured: Week 24
Acceptability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)
Participants or legal guardian will be asked:
- about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3).
- about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)
Measured: Week 48
Palatability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)
Participants or legal guardian will be asked about the study drug taste
Measured: Week 48
Acceptability of B/F/TAF Formulation at Week 1 (Cohort 4)
Participants or legal guardian will be asked about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste
Measured: Week 1
Palatability of B/F/TAF Formulation at Week 1 (Cohort 4)
Participants or legal guardian will be asked about the study drug taste
Measured: Week 1
Acceptability of B/F/TAF Formulation at Week 2 (Cohort 4)
Participants or legal guardian will be asked about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste
Measured: Week 2
Palatability of B/F/TAF Formulation at Week 2 (Cohort 4)
Participants or legal guardian will be asked about the study drug taste
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start21 Sep 2016
- Primary completion24 Mar 2025
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881320
- Sponsor's protocol ID
- GS-US-380-1474
- Other IDs
- 2016-002345-39, 2016
- Status last verified
- Sep 2026
- First submitted
- 23 Aug 2016
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38621393Gaur 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.
PubMed 34302760
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
- ClinicalTrials.gov ID
- NCT02881320
- Acronym / sponsor ID
- GS-US-380-1474
- Conditions
- HIV-1 Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg) | Experimental | Drug: B/F/TAF (Adult Strength)* 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. |
| Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg) | Experimental | Drug: B/F/TAF (Adult Strength)* 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. |
| Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg) | Experimental | Drug: B/F/TAF (Low Dose)* 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. |
| Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg) | Experimental | Drug: B/F/TAF (TOS)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. |
| Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg) | Experimental | Drug: B/F/TAF (TOS)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. |
| Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg) | Experimental | Drug: B/F/TAF (TOS)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. |
| Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg) | Experimental | Drug: B/F/TAF (TOS)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. |
| Open-Label Extension | Experimental | Drug: B/F/TAF (Adult Strength), Drug: B/F/TAF (Low Dose), Drug: B/F/TAF (TOS)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. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B/F/TAF (Adult Strength)Also: Biktarvy®, GS-9883/F/TAF50/200/25 mg FDC tablets administered orally once daily without regard to food. | Drug | Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg), Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg), Open-Label Extension |
| B/F/TAF (Low Dose)Also: GS-9883/F/TAF30/120/15 mg FDC tablets administered orally once daily without regard to food. | Drug | Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg), Open-Label Extension |
| B/F/TAF (TOS)Also: GS-9883/F/TAF2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily. | Drug | Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg), Open-Label Extension |
| B/F/TAF (TOS)Also: GS-9883/F/TAF2 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. | Drug | Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg), Open-Label Extension |
| B/F/TAF (TOS)Also: GS-9883/F/TAF1 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. | Drug | Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg), Open-Label Extension |
| B/F/TAF (TOS)Also: GS-9883/F/TAF1 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 | Drug | Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg), Open-Label Extension |
Primary outcome
PK Parameter: AUCtau of Bictegravir
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Up to 24 weeks
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24
Time frame: Up to 24 weeks
36 secondary outcomes
Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm
Time frame: Week 24
Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Time frame: Week 48
Change from Baseline in CD4+ Cell Counts at Week 24
Time frame: Baseline, Week 24
Change from Baseline in CD4+ Cell Counts at Week 48
Time frame: Baseline, Week 48
Change from Baseline in CD4+ Cell Count Percentages at Week 24
Time frame: Baseline, Week 24
Change from Baseline in CD4+ Cell Count Percentages at Week 48
Time frame: Baseline, Week 48
PK Parameter: Tmax of Bictegravir
Time frame: 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
PK Parameter: Cmax of Bictegravir
Time frame: 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
PK Parameter: AUClast of Bictegravir
Time frame: 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
PK Parameter: T1/2 of Bictegravir
Time frame: 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
PK Parameter: Apparent Clearance (CL) of Bictegravir
Time frame: 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
PK Parameter: Apparent Vz of Bictegravir
Time frame: 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
PK Parameter: AUCtau of TAF and FTC
Time frame: 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
PK Parameter: AUClast of TAF and FTC (Cohorts 1, 2, and 3)
Time frame: 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
PK Parameter: AUClast of FTC (Cohorts 4)
Time frame: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: Cmax of TAF and FTC (Cohorts 1, 2, and 3)
Time frame: 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
PK Parameter: Cmax of FTC (Cohorts 4)
Time frame: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
PK Parameter: Ctau of TAF and FTC
Time frame: 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
PK Parameter: Tmax of TAF and FTC
Time frame: 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
PK Parameter: T1/2 of TAF and FTC
Time frame: 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
PK Parameter: Apparent CL of TAF and FTC
Time frame: 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
PK Parameter: Apparent Vz of TAF and FTC
Time frame: 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
Percentage of Participants Experiencing Treatment-Emergent Adverse Events Through Week 48
Time frame: Up to 48 weeks
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48
Time frame: Up to 48 weeks
Acceptability of B/F/TAF Formulation at Day 1 (All Cohorts)
Time frame: Day 1
Palatability of B/F/TAF Formulation at Day 1 (All Cohorts)
Time frame: Day 1
Acceptability of B/F/TAF Formulation at Week 4 (All Cohorts)
Time frame: Week 4
Palatability of B/F/TAF Formulation at Week 4 (All Cohorts)
Time frame: Week 4
Acceptability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)
Time frame: Week 24
Palatability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)
Time frame: Week 24
Acceptability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)
Time frame: Week 48
Palatability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)
Time frame: Week 48
Acceptability of B/F/TAF Formulation at Week 1 (Cohort 4)
Time frame: Week 1
Palatability of B/F/TAF Formulation at Week 1 (Cohort 4)
Time frame: Week 1
Acceptability of B/F/TAF Formulation at Week 2 (Cohort 4)
Time frame: Week 2
Palatability of B/F/TAF Formulation at Week 2 (Cohort 4)
Time frame: Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 38621393Rodriguez 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.
- Derived from this study: PubMed 34302760Gaur 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.
- Individual participant dataSharing planned: No
Related trials for HIV-1 Infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing B/F/TAF (Adult Strength), B/F/TAF (Low Dose) and B/F/TAF (TOS) in people with HIV-1 Infection, run by Gilead Sciences at 25 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, South Africa, Thailand, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK Parameter: AUCtau of Bictegravir (time frame: 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881320, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.