NCT05911360 - A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF | Crick

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants living with HIV-1 with documented plasma HIV-1 RNA \<50 c/mL within 3 months prior to Screening. * Participants must have been on uninterrupted antiretroviral therapy (ART) for ≥1 year (except for brief periods \[less than 30 days\] where all ART was stopped due to tolerability and/or safety concerns). * Participants must be on uninterrupted BIC/FTC/TAF for at least 6 months prior to Screening. * Participants with plasma HIV-1 RNA \<50 c/mL at Screening. * Participants with no known prior regimen switches due to documented virologic failure (defined as a confirmed plasma HIV 1 RNA ≥200 c/mL). * Participants with unknown full treatment/clinical history beyond 5 years prior to Screening may be eligible upon discussion and agreement with the medical monitor. Exclusion Criteria: * Women participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study. * Participants with any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/cubic millimetre (mm\^3) are not exclusionary. * Participants with signs and symptoms which, in the opinion of the Investigator, are suggestive of active severe acute respiratory syndrome-related coronavirus (SARS-CoV-2) infection within 14 days prior to enrolment. * Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification. * Evidence of hepatitis B virus (HBV) infection based on the results of testing at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: 1. Participants positive for HBsAg are excluded; 2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded; 3. Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. * Participants with unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). * Participants with history of liver cirrhosis with or without hepatitis viral co-infection. * Participants with untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible. * Participants with history or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia. * Participants who in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. * Participants with any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major Integrase strand transfer inhibitor (INSTI) resistance associated mutation in any available prior resistance genotype assay test result. All available historical resistance reports with HIV-1 reverse transcriptase or integrase genotypic data must be provided to ViiV after screening and before enrollment for review by ViiV Virology. * Participants with any verified Grade 4 laboratory abnormality with the exception of Grade 4 lipid abnormalities. * Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN) or ALT ≥3xULN and bilirubin ≥1.5xULN (with greater than \[\>\]35 percentage \[%\] direct bilirubin). * Participant has estimated creatine clearance \<30 millilitres per minute (mL/min) per 1.73 square meter (m\^2) using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr\_R) method.

Outcomes

Primary Outcomes

Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) at Week 48

Participants with HIV-1 RNA \>= 50 c/mL were evaluated. Virologic outcome was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the Week 48 Window. The analysis was done using the modified Snapshot algorithm.

Time frame: At Week 48

Secondary Outcomes

Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 24

The number of participants with plasma HIV-1 RNA \>/=50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.

Time frame: At Week 24

Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: At Week 96

Number of Participants With Plasma HIV-1 RNA Less Than (<) 50 c/mL at Week 24

The number of participants with plasma HIV-1 RNA \<50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.

Time frame: At Week 24

Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 48

The number of participants with plasma HIV-1 RNA \< 50 c/mL at Week 48 was analyzed using the modified Snapshot Algorithm.

Time frame: At Week 48

Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: At Week 96

Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at Week 24

Time frame: At Week 24

Absolute Values for CD4+ Cells Count at Week 48

Time frame: At Week 48

Absolute Values for CD4+ Cells Count at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: At Week 96

Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at Week 24

The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

Time frame: At Week 24

Absolute Values for CD4:CD8 Ratio at Week 48

The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

Time frame: At Week 48

Absolute Values for CD4:CD8 Ratio at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: At Week 96

Change From Baseline in CD4+ Cells Count at Week 24

Time frame: At Week 24 compared to Baseline

Change From Baseline in CD4+ Cells Count at Week 48

Time frame: At Week 48 compared to Baseline

Change From Baseline in CD4+ Cells Count at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: At Week 96 compared to baseline

Change From Baseline in CD4:CD8 Ratio at Week 24

The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

Time frame: At Week 24 compared to Baseline

Change From Baseline in CD4:CD8 Ratio at Week 48

The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

Time frame: At Week 48 compared to Baseline

Change From Baseline in CD4:CD8 Ratio at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: At Week 96 compared to baseline

Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 24

Occurrence of disease progression was evaluated through HIV-associated conditions and incidence of disease progression to United States Centers for Disease Control and Prevention (CDC) stage 3 or death.

Time frame: Up to Week 24

Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 48

Time frame: Up to Week 48

Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 96

Time frame: Week 96

Number of Participants With Viral Resistance After Meeting Confirmed Virologic Withdrawal (CVW) Criterion

Confirmed virologic withdrawal criteria is defined as two consecutive assessments with HIV-1 RNA greater than or equal to (\>=)200 c/mL after Day 1 visit.

Time frame: Up to Week 48

Number of Participants With Viral Resistance After Meeting CVW Criterion

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: From Week 48 to Week 96

Number of Participants With Treatment Related Non-serious Adverse Events (AEs)

A treatment related non-serious AE is defined as any untoward medical occurrence in a clinical study participant considered related to the study treatment. Any = occurrence of the event regardless of intensity grade

Time frame: Up to Week 48

Number of Participants With Treatment Related Non-serious AEs

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: From Week 48 to Week 96

Number of Participants With Any Serious Adverse Events (SAEs)

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.

Time frame: Up to Week 48

Number of Participants With SAEs

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: From Week 48 to Week 96

Number of Participants With AEs Leading to Treatment Discontinuation

Time frame: Up to Week 48

Number of Participants With AEs Leading to Treatment Discontinuation

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame: From Week 48 to Week 96

A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF

Overview

Conditions

Interventions

Eligibility

Locations (56)

Outcomes

Primary Outcomes

Secondary Outcomes