Clinical Research Directory

Inclusion Criteria: * Age between 18 years and 70 years old at the time of obtaining informed consent. * Persons of any sex or gender are eligible. Note: Participants of childbearing potential (POCBP) are eligible to participate if not pregnant, not lactating, and agreeing to adhere to study requirements for use of contraception and pregnancy avoidance. * Participant has a documented diagnosis of HIV-1 infection Note: Participants in Population 1 must have a documented positive HIV antibody result available for Screening. Population 1 only: * Plasma HIV-1 RNA \>=2000 copies/milliliter (c/mL) at Screening. * CD4+ T cell count \>=300 cells/microliter (μL) at Screening. * Antiretroviral treatment naïve, defined as no exposure to ART after a diagnosis of HIV-1 infection, prior to enrollment. Population 2 only: * Participant is stably virologically suppressed (plasma HIV-1 RNA \<50 c/mL). * Documented evidence of uninterrupted treatment with oral non-boosted INSTI-based ART for at least 6 months prior to Screening, as well as uninterrupted treatment with ART (any guideline-recommended oral regimen) for at least 24 months prior to Screening. * CD4+ T cell count \>=450 cells/μL at Screening. * Body weight \>=50 kg to \<=115 kg. * Participant is capable of giving written informed consent, which includes adherence to the requirements and restrictions listed in the consent form and in the protocol. Exclusion Criteria: CONCURRENT MEDICAL CONDITIONS \& MEDICAL HISTORY * Participant is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study. * Participant has documented diagnosis of HIV-2 infection. * Participant is known to have acquired HIV via perinatal transmission. * Any evidence of a current or known past Center for Disease Control and Prevention (CDC) Stage 3 disease. * Any ongoing malignancy or history of systemic cancers, such as Kaposi's sarcoma and lymphoma, or other virus-associated malignancies. * Ongoing or clinically relevant pancreatitis. * Current HIV-related kidney disease. * History of or active HIV-associated dementia or progressive multifocal leukoencephalopathy. CARDIAC \& CARDIOVASCULAR CONDITIONS • Participants who are at clinically significant risk of cardiovascular disease. * Ongoing or any lifetime history of clinically significant cardiovascular or cardiac disease. * Confirmed QTcF value outside normal range at Screening or Day 1. HEPATIC CONDITIONS • History of clinically relevant hepatitis in the 6 months prior to Screening. * Participants with severe hepatic impairment. * Advanced MAFLD and advanced non-alcoholic steatohepatitis, if evidence for substantial fibrosis (fibrosis score ≥F2) or evidence of cirrhosis. * Unstable liver disease. * History of liver cirrhosis with or without hepatitis viral co-infection. NEUROPSYCHIATRIC CONDITIONS • Participants who pose a significant suicide risk. LABORATORY DIAGNOSTIC ASSESSMENTS * Participants who are experiencing (Population 1) or are known to have initiated ART during (Population 2) acute HIV infection. * Any verified Grade 4 laboratory abnormality at Screening, excluding asymptomatic elevations of lipids or CPK. * Alanine transferase (ALT) \>=3 times the upper limit of normal (ULN) at Screening. * Estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m\^2. * Hemoglobin \>=Grade 2 at Screening. * Platelets \>=Grade 2 at Screening. * Absolute Neutrophil Count (ANC) ≥Grade 2 at Screening. * Any acute abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's inclusion in an interventional clinical study. Population 2 only • Two or more plasma HIV-1 RNA results \>=50 c/mL in the 18 months prior to Screening. INFECTIOUS DISEASES * Active hepatitis B virus (HBV) co-infection. * Active hepatitis C virus (HCV) co-infection. * Participant has untreated syphilis before enrolment. * Known current untreated or incompletely treated active Mycobacterium TB infection. ANTIRETROVIRAL RESISTANCE • Known major resistance-associated mutations to second-generation INSTIs or to antiretroviral (ARV) agents from 2 or more drug classes. PRIOR AND CONCOMITANT MEDICATIONS * Prior use of any of the following agents: o long-acting ARVs (any dose in the past 24 months or within 5 half-lives \[whichever is longer\]) o FTR (any lifetime use) * HIV-1 immunotherapeutic vaccines or prophylactic vaccines (any lifetime use) * HIV-1 monoclonal antibody therapy (any lifetime use). * Prior receipt of any approved or experimental non-HIV vaccination within 2 weeks prior to study enrolment. * History of systemic corticosteroids, immunosuppressive anti-cancer, interleukins, systemic interferons, or systemic chemotherapy, within 6 months prior to Screening. * Participant has received an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent (whichever is longer), prior to enrolment. * Treatment with any of the following agents within 30 days of enrolment: o radiation therapy o cytotoxic chemotherapeutic agents * anti-tuberculosis therapy * immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. * Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication. Prohibited medications must be stopped within 7 days (or 14 days if the drug is a potential CYP3A4 enzyme inducer) or 5 half-lives (whichever is longer), prior to enrolment. Population 1 only • Known use of PrEP or PEP within \<30 days (for oral agents) or \<52 weeks (for LA parenteral agents) of HIV-1 diagnosis. Participants with a documented seronegative result \>=30 days after the last dose of oral PrEP or PEP (or \>=52 weeks after the last dose of LA PrEP) are not excluded. Population 2 only • Current use of NNRTI-containing ART. OTHER EXCLUSIONS * History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that contraindicates study participation. * Any condition which may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study drugs. * Any pre-existing physical or mental condition (including substance use disorder) which, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Participant is currently participating in, or anticipates being selected for, any other interventional study.