Comparing 4 approaches for HIV infections

Exclusion

• −History of sensitivity to any of the study medications, or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → or ViiV Healthcare medical monitor, contraindicates their participation.
• −Participants with acute HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
• −History of cirrhosis with or without viral hepatitis co-infection.
• −Participants with HCV co-infection will be excluded from the study.
• −Individuals who are co-infected with HIV and HBV will be excluded Participants diagnosed with syphilis at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → (i.e., positive syphilis testing) should be treated as per local guidelines and will be eligible to enroll at any time regardless of the stage of disease.
• −Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of Day 1.
• −Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
• −Participants with known or suspected presence of virologic resistance mutations as defined by the Stanford HIV Drug Resistance Database to INSTIs or NRTIs. This determination will be based on local virologic resistance testing, either at Screening or within the 3 months prior to Screening. ViiV Healthcare clinical virologist and/or ViiV Healthcare medical monitor will verify eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → to this criterion prior to Day 1.
• −Any evidence of an active Centres for Disease ControlControl groupThe group a new treatment is measured against.Read more → and Prevention (CDC) Stage 3 disease \[CDC 2014\], except cutaneous Kaposi's sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less than 200 cells/µL are not exclusionary.
• −Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
• −Uncontrolled malignancy is excluded, whereas participants who have controlled malignancies may be included in agreement between the investigator and the ViiV Healthcare medical monitor.
• −Any pre-existing physical, or mental condition (including alcohol or drug abuse) which, in the opinion of the investigator (with or without psychiatric evaluation) or the ViiV Healthcare medical monitor, may interfere with the participant's ability to comply with the dosing schedule and/or protocolProtocolThe detailed plan a study must follow.Read more → evaluations or which may compromise the safety of the participant.
• −Any condition which, in the opinion of the investigator or the ViiV Healthcare medical monitor, that may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication and normal gastrointestinal anatomy or motility or hepatic and/or renal function
• −Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
• −Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
• −Exposure to an approved vaccine within 14 days prior to Day 1.
• −Current enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → or past participation within the last 30 days before signing of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → in any other clinical study involving an investigational study intervention or any other type of medical research
• −Creatinine clearance (eGFR) of \<60 mL/min/1.73 m2 via CKD-EPI race neutral method \[Delgado, 2021\].
• −ALT \>3 times the upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.
• −Any Grade 4 laboratory abnormality at screening, except for a Grade 4 CPK and lipid abnormalities (e.g., total cholesterol, triglycerides, etc.) will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the ViiV Healthcare medical monitor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility.
• −Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
• −Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for screening ECG (a single repeat is allowed for eligibility determination and will be the screening ECG entered into the eCRF): QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 msec (males) or \>470 msec (females); \>480 msec for participants with bundle branch block.
• −Participants who are breastfeeding or plan to breastfeed during the study.
• −Clinically significant CV disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
• −Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.