Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

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.