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

NCT05911360 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: 2195162022-503137-66-00
• Study Type: interventional
• Target: 205
• Locations: 12 countries
• Sites: 56

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.

Conditions

HIV; HIV Infections

Keywords

Human Immunodeficiency Virus (HIV)-1; Dolutegravir; Lamivudine; Bictegravir; Emtricitabine; Tenofovir alafenamide; Dovato; Biktarvy; Switch study; ≥ 50 years

Outcome Measures

Primary Outcomes (1)

• 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

  Week 48

Secondary Outcomes (9)

• Number of Participants With Plasma HIV-1 RNA ≥50 c/mL per Snapshot Algorithm at 24 and 96 Weeks

  Weeks 24 and 96

• Number of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL per Snapshot Algorithm at 24, 48 and 96 Weeks

  Weeks 24,48, and 96

• Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at 24, 48 and 96 Weeks

  Weeks 24,48, and 96

• Change From Baseline in CD4+ Cells Count at 24, 48 and 96 Weeks

  Baseline (Day 1) and at Weeks 24,48, and 96

• Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at 24, 48 and 96 Weeks

  Weeks 24,48, and 96

Study Arms (1)

Participants Receiving DTG/3TC FDC

EXPERIMENTAL

Drug: DTG/3TC

Interventions

DTG/3TC DRUG

DTG/3TC FDC will be administered once daily.

Participants Receiving DTG/3TC FDC

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
• 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:
• Participants positive for HBsAg are excluded;
• Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded;
• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (56)

GSK Investigational Site

Phoenix, Arizona, 85015, United States

Location

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

Palm Springs, California, 92262, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20005, United States

Location

GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

Location

GSK Investigational Site

Miami, Florida, 33133, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33407, United States

Location

GSK Investigational Site

Augusta, Georgia, 30912, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Macon, Georgia, 31201, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02043, United States

Location

GSK Investigational Site

Berkley, Michigan, 48072, United States

Location

GSK Investigational Site

Detroit, Michigan, 48202, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64111, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68198, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89106, United States

Location

GSK Investigational Site

The Bronx, New York, 10467, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28204, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27401, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28401-7684, United States

Location

GSK Investigational Site

Akron, Ohio, 44304, United States

Location

GSK Investigational Site

Portland, Oregon, 97239, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Innsbruck, 6020, Austria

Location

GSK Investigational Site

Vienna, 1100, Austria

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 1N9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

Location

GSK Investigational Site

Nice, 6202, France

Location

GSK Investigational Site

Orléans, 45100, France

Location

GSK Investigational Site

Paris, 75004, France

Location

GSK Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

GSK Investigational Site

Hanover, 30625, Germany

Location

GSK Investigational Site

München, 80336, Germany

Location

GSK Investigational Site

Milan, 20142, Italy

Location

GSK Investigational Site

Modena, 41100, Italy

Location

GSK Investigational Site

Roma, 161, Italy

Location

GSK Investigational Site

Torino, 10149, Italy

Location

GSK Investigational Site

Mérida, 97070, Mexico

Location

GSK Investigational Site

Monterrey, 64460, Mexico

Location

GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

GSK Investigational Site

Rotterdam, 3079 DZ, Netherlands

Location

GSK Investigational Site

Utrecht, 3584 CX, Netherlands

Location

GSK Investigational Site

Porto, 4099-001, Portugal

Location

GSK Investigational Site

Porto, 4200-319, Portugal

Location

GSK Investigational Site

Vila Nova de Gaia, 4434-502, Portugal

Location

GSK Investigational Site

Guadalajara, 19002, Spain

Location

GSK Investigational Site

Manresa Barcelona, 08243, Spain

Location

GSK Investigational Site

Sabadell Barcelona, 8208, Spain

Location

GSK Investigational Site

Zaragoza, 50009, Spain

Location

GSK Investigational Site

Liverpool, L7 8XP, United Kingdom

Location

GSK Investigational Site

London, SE1 9RT, United Kingdom

Location

GSK Investigational Site

London, SW7 2AZ, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 22, 2023
• Study Start: January 31, 2023
• Primary Completion: February 24, 2025
• Study Completion: January 13, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (24); FR (3); ME (2); PT (3); GB (3); AU (2); ES (4); NL (3); BE (2); IT (4); CA (3); DE (3)