Overview
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
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.