study of bictegravir/lenacapavir in children and adolescents with hiv-1

Conditions: HIV-1-infection

Summary: the goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (bic/len) and to learn how the study drug interacts with the body in virologically suppressed (vs) children and adolescents with human immunodeficiency virus type 1 (hiv-1) on a stable and complex antiretroviral (arv) regimen. the study will also assess the safe loading dose of len and pharmacokinetics (pk) of bic/len. the primary objectives of this study are: * to evaluate the steady-state pk of bic and len and confirm the dose of the len loading dose and bic/len fdc in vs children and adolescents with hiv-1. * to evaluate the safety and tolerability of bic/len through week 24 in vs children and adolescents with hiv-1.


Eligibility criteria:
key inclusion criteria: * age and body weight at screening: * cohort 1: ≥ 12 years to \< 18 years weighing ≥ 35 kg. * cohort 2: ≥ 6 years to \< 12 years weighing ≥ 25 kg to \< 35 kg. * cohort 3: ≥ 2 years to \< 6 years weighing ≥ 10 kg to \< 25 kg. * on a complex arv regimen. complex regimens are any arv therapy that is not a single-tablet regimen taken once daily (eg, \> 1 tablet or any other formulation a day). * documented plasma hiv-1 ribonucleic acid (rna) levels must be \< 50 copies/ml (or undetectable hiv-1 rna level according to the local assay being used if the limit of detection is \< 50 copies/ml) in the last 6 months prior to screening (at least 1 measure prior to screening). * plasma hiv-1 rna levels \< 50 copies/ml at screening. * no documented or suspected resistance to integrase strand transfer inhibitors (mutations t66a/i/k, e92g/q/v, g118r, f121c/y, g140r, y143c/h/r, s147g, q148h/k/r, n155h/s, or r263k in the integrase gene). * the following laboratory parameters at screening: * estimated glomerular filtration rate ≥ 30 ml/min/1.73 m2 using the bedside schwartz formula. * absolute neutrophil count \> 0.50 cells/l (\> 500 cells/mm3). * hemoglobin ≥ 85 g/l (\> 8.5 g/dl). * platelets ≥ 50 cells/l (≥ 50,000 cells/mm3). * hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 x upper limit of normal. * total bilirubin ≤ 23 μmol/l (≤ 1.5 mg/dl) and direct bilirubin ≤ 7 μmol/l (≤ 0.4 mg/dl). key exclusion criteria: * cd4 cell count \< 200 cells/mm\^3. * cd4 percentage \< 20%. * life expectancy ≤ 1 year. * an opportunistic illness indicative of stage 3 hiv diagnosed within the 30 days prior to screening. * evidence of active pulmonary or extrapulmonary tuberculosis within 3 months prior to screening. * acute hepatitis within 30 days prior to screening. * positive hepatitis c virus (hcv) antibody with detectable hcv rna (participants positive for hcv antibody will have an hcv rna test performed). * positive hepatitis b surface antigen (hbsag) or positive hepatitis b virus (hbv) core antibody (antibody against hepatitis b core antigen \[anti-hbc\]) at screening. if a participant is negative for hbsag and positive for anti-hbc but hbv dna is undetectable, the participant may be enrolled. * a history of or current decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).current alcohol or substance use judged by the investigator to potentially interfere with the participant's study compliance. note: other protocol defined inclusion/exclusion criteria may apply.