Clinical trial 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
Official title: A Phase 3b, Multicenter, Single-arm, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to DTG/3TC Single Tablet Regimen Administered Once Daily From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in People Living With HIV of at Least 50 Years of Age Who Are Virologically Suppressed
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HIV
HIV Infections
Keywords: Human Immunodeficiency Virus (HIV)-1
Dolutegravir
Lamivudine
Bictegravir
Emtricitabine
Tenofovir alafenamide
Dovato
Biktarvy
Switch study
≥ 50 years
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 206
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (≥)50 Copies/Millilitre (c/mL) per Snapshot Algorithm at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Number of Participants With Plasma HIV-1 RNA ≥50 c/mL per Snapshot Algorithm at 24 and 96 Weeks
timeFrame: Weeks 24 and 96
measure: Number of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL per Snapshot Algorithm at 24, 48 and 96 Weeks
timeFrame: Weeks 24,48, and 96
measure: Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at 24, 48 and 96 Weeks
timeFrame: Weeks 24,48, and 96
measure: Change From Baseline in CD4+ Cells Count at 24, 48 and 96 Weeks
timeFrame: Baseline (Day 1) and at Weeks 24,48, and 96
measure: Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at 24, 48 and 96 Weeks
timeFrame: Weeks 24,48, and 96
measure: Change From Baseline in CD4:CD8 Ratio at 24, 48 and 96 Weeks
timeFrame: Baseline (Day 1) and at Weeks 24,48, and 96
measure: Number of Participants With Disease Progression Through Weeks 24, 48 and 96
timeFrame: Weeks 24, 48, and 96
measure: Number of Participants who Meet Confirmed Virologic Withdrawn Criterion With Viral Resistance Over Time
timeFrame: Up to Week 96
measure: Number of Participants With Treatment Related Non-serious Adverse Events, all Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation
timeFrame: Up to Week 96
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Palm Springs
country: United States
facility: GSK Investigational Site
state: California
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Fort Pierce
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Macon
country: United States
facility: GSK Investigational Site
state: Georgia
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Berkley
country: United States
facility: GSK Investigational Site
state: Michigan
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Akron
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Lynchburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Innsbruck
country: Austria
facility: GSK Investigational Site
city: Linz
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Nice Cedex 3
country: France
facility: GSK Investigational Site
city: Orléans
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Tourcoing
country: France
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: München
country: Germany
facility: GSK Investigational Site
city: Modena
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: García Gineres
country: Mexico
facility: GSK Investigational Site
state: Mérida
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Porto
country: Portugal
facility: GSK Investigational Site
city: Porto
country: Portugal
facility: GSK Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: GSK Investigational Site
city: Sabadell
country: Spain
facility: GSK Investigational Site
state: Barcelona
city: Guadalajara
country: Spain
facility: GSK Investigational Site
city: Manresa (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
Study officials:
References: