Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
- Conditions
- HIV-1-infection
- Interventions
- Drug: B/F/TAFDrug: Placebo to match B/F/TAFDrug: Placebo to match BIC/LEN
- Registration Number
- NCT06333808
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH).
The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 577
- Currently receiving B/F/TAF for at least 6 months prior to screening.
- If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
- At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL.
- Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- No documented or suspected resistance to BIC (including integrase strand-transfer inhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
- No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
- Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance.
Key
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Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.
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Breastfeeding (nursing).
-
Prior use of, or exposure to, LEN.
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Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.
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Active tuberculosis infection.
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Acute hepatitis < 30 days before randomization.
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Chronic hepatitis B virus (HBV) infection, as determined by either:
- Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
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Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.
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History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
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Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
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Active malignancy requiring acute systemic therapy.
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Any of the following laboratory values at screening:
- Alanine aminotransferase > 5 × upper limit of normal (ULN).
- Direct bilirubin > 1.5 × ULN.
- Platelets < 50,000/mm^3.
- Hemoglobin < 8.0 g/dL.
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Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol.
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Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
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Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF Lenacapavir Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN Lenacapavir Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN B/F/TAF Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN Placebo to match BIC/LEN Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF Placebo to match B/F/TAF Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF Bictegravir Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN Bictegravir Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.
- Primary Outcome Measures
Name Time Method Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm Week 48
- Secondary Outcome Measures
Name Time Method Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96 Baseline; Week 96 Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96 From first dose date up to Week 96 Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm Week 48 Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48 Baseline; Week 48 Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm Week 96 Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm Week 96 Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48 From first dose date up to Week 48
Trial Locations
- Locations (102)
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC)
🇨🇦Vancouver, Canada
Cool Aid Community Health Centre
🇨🇦Victoria, Canada
Instituto Dominicano de Estudios Virologicos - IDEV
🇩🇴Santo Domingo, Dominican Republic
Praxis Dr. Knechten
🇩🇪Aachen, Germany
Novopraxis Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Universitätsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Praxis am Ebertplatz
🇩🇪Köln, Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
🇩🇪Munchen, Germany
LMU Klinikum der Universität
🇩🇪Munich, Germany
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
🇮🇹Brescia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti (Policlinico di Foggia)
🇮🇹Foggia, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo
🇮🇹Monza, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
🇮🇹Pavia, Italy
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
🇮🇹Roma, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
🇮🇹Roma, Italy
National Hospital Organization Nagoya Medical Center
🇯🇵Aichi, Japan
Regina General Hospital
🇨🇦Regina, Canada
Pueblo Family Physicians
🇺🇸Phoenix, Arizona, United States
Be Well Medical Center
🇺🇸Berkeley, California, United States
Pacific Oaks Medical Group
🇺🇸Beverly Hills, California, United States
Ruane Clinical Research Group Inc.
🇺🇸Los Angeles, California, United States
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
🇺🇸Oakland, California, United States
BIOS Clinical Research
🇺🇸Palm Springs, California, United States
UCSD Anti Viral Research Centre (AVRC)
🇺🇸San Diego, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Mills Clinical Research
🇺🇸West Hollywood, California, United States
Public Health Institute at Denver Health
🇺🇸Denver, Colorado, United States
Yale University School of Medicine (study visits)
🇺🇸New Haven, Connecticut, United States
Midland Florida Infectious Diseases Specialists, PL - Orange City
🇺🇸DeLand, Florida, United States
Therafirst Medical Center
🇺🇸Fort Lauderdale, Florida, United States
CAN Community Health
🇺🇸Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
AIDS Healthcare Foundation - The Kinder Medical Group
🇺🇸Miami, Florida, United States
Schiff Center for liver Diseases/University of Miami
🇺🇸Miami, Florida, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Bliss Healthcare
🇺🇸Orlando, Florida, United States
AHF Pensacola
🇺🇸Pensacola, Florida, United States
CAN community Health
🇺🇸Sarasota, Florida, United States
Triple O Research Institute, P.A.
🇺🇸West Palm Beach, Florida, United States
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
Mercer University, Department of Internal Medicine
🇺🇸Macon, Georgia, United States
Claudia T Martorell MD LLC dba The Research Institute
🇺🇸Springfield, Massachusetts, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
KC Care health Center
🇺🇸Kansas City, Missouri, United States
Southampton Community Healthcare, Inc.
🇺🇸Saint Louis, Missouri, United States
ID Care, LLC
🇺🇸Hillsborough, New Jersey, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
New Jersey Medical School - Clinical Research Center
🇺🇸Newark, New Jersey, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
AXCES Research Group, LLC
🇺🇸Salt Lake City, Utah, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
New York-Presbyterian Queens
🇺🇸Flushing, New York, United States
The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care
🇺🇸Greenville, North Carolina, United States
Rosedale Health and Wellness
🇺🇸Huntersville, North Carolina, United States
Philadelphia FIGHT Community Health Centers
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC) Research Nexus
🇺🇸Charleston, South Carolina, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
St Hope Foundation, Inc.
🇺🇸Bellaire, Texas, United States
AIDS Arms, Inc. DBA Prism Health North Texas
🇺🇸Dallas, Texas, United States
North Texas Infectious Diseases Consultants, PA
🇺🇸Dallas, Texas, United States
Texas Centers for Infectious Disease Associates
🇺🇸Fort Worth, Texas, United States
The Crofoot research Center, INC.
🇺🇸Houston, Texas, United States
Clinical Alliance For Research & Education - Infectious Diseases. LLC (CARE-ID)
🇺🇸Annandale, Virginia, United States
Peter Shalit MD
🇺🇸Seattle, Washington, United States
Community Health care
🇺🇸Tacoma, Washington, United States
Helios Salud S.A.
🇦🇷Buenos Aires, Argentina
Fundacion Huesped
🇦🇷Buenos Aires, Argentina
Instituto CAICI SRL
🇦🇷Santa Fe, Argentina
Taylor Square Private Clinic
🇦🇺Darlinghurst, New South Wales, Australia
Alfred Hospital(Alfred Health)
🇦🇺Melbourne, Victoria, Australia
Prahran Market Clinic
🇦🇺South Yarra, Victoria, Australia
Chronic Viral Illness Service/McGill University Health Centre (MUHC)
🇨🇦Decarie Montreal, Canada
Clinique Médicale l'Actuel
🇨🇦Montreal, Canada
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Canada
Center Hospital of the National Center for Global Health and Medicine
🇯🇵Tokyo, Japan
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
National Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Unidad de Atencion Medica e Investigacion en Salud
🇲🇽Merida, Mexico
ProcliniQ Investigacion Clinica Toriello Guerra, Tlalpan
🇲🇽Mexico City, Mexico
HOPE Clinical Research
🇵🇷San Juan, Puerto Rico
Proyecto ACTU
🇵🇷San Juan, Puerto Rico
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario La Paz - PPDS
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio - PPDS
🇪🇸Sevilla, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare
🇨🇳Taoyuan City, Taiwan
Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool Hospital
🇬🇧Liverpool, United Kingdom
King's College Hospital, Weston Education Centre
🇬🇧London, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust, St Stephen's Centre, Chelsea and Westminster Hospital
🇬🇧London, United Kingdom
St Mary's Hospital - PPDS
🇬🇧London, United Kingdom
Mortimer Market Centre
🇬🇧London, United Kingdom