study of bictegravir/emtricitabine/tenofovir alafenamide fixed dose combination in adolescents and children with human immunodeficiency virus-1

Conditions: HIV-1 Infection

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 criteria:
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 \ 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.