study to compare bictegravir/lenacapavir versus current therapy in people with hiv-1 who are successfully treated with biktarvy

Conditions: HIV-1-infection

Summary: the goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (bic)/lenacapavir (len), fixed-dose combination (fdc) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) fdc in people living with hiv-1 (pwh). the primary objective of this study is to learn how effective it is to switch to bic/len fdc tablets versus continuing on b/f/taf fdc tablets in virologically suppressed pwh.


Eligibility criteria:
key inclusion criteria: * currently receiving b/f/taf for at least 6 months prior to screening. * if plasma human immunodeficiency virus type 1 (hiv-1) ribonucleic acid (rna) measurements in the last 6 months prior to screening are available, all levels must be \< 50 copies/ml. * at least one documented hiv-1 rna level measured between 6 and 12 months (± 2 months) prior to screening. this and any other hiv-1 rna measurements documented in this period must be \< 50 copies/ml. * plasma hiv-1 rna levels \< 50 copies/ml at screening. * no documented or suspected resistance to bic (including integrase strand-transfer inhibitor resistant (insti-r) mutations t66a/i/k, e92g/q, g118r, f121y, y143c/h/r, s147g, q148h/k/r, n155h/s, or r263k in the integrase gene). * no documented or suspected resistance to tenofovir alafenamide (taf) (taf; mutations k65r, k65n, k70e, q151m or t69 insertion, or ≥ 3 of the following thymidine analog mutations \[m41l, d67n, k70r, l210w, t215y/f, k219q/e/n/r\] in the reverse transcriptase gene). * estimated glomerular filtration rate ≥ 30 ml/min according to the cockcroft-gault formula for creatinine clearance. key exclusion criteria: * positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to day 1 randomization. * breastfeeding (nursing). * prior use of, or exposure to, len. * active, serious infections (other than hiv-1) requiring parenteral therapy \< 30 days prior to randomization. * active tuberculosis infection. * acute hepatitis \< 30 days before randomization. * chronic hepatitis b virus (hbv) infection, as determined by either: * positive hbv surface antigen and negative hbv surface antibody, regardless of hbv core antibody status, at the screening visit. * positive hbv core antibody and negative hbv surface antibody, regardless of hbv surface antigen status, at the screening visit. * known hypersensitivity to the study drug, its metabolites, or any formulation excipient. * history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding). * abnormal electrocardiogram (ecg) at the screening visit that is clinically significant as determined by the investigator. * active malignancy requiring acute systemic therapy. * any of the following laboratory values at screening: * alanine aminotransferase \> 5 × upper limit of normal (uln). * direct bilirubin \> 1.5 × uln. * platelets \< 50,000/mm\^3. * hemoglobin \< 8.0 g/dl. * requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol. * participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor. * any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements. note: other protocol defined inclusion/exclusion criteria may apply.