Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
NCT ID: NCT05502341
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
689 participants
INTERVENTIONAL
2022-08-16
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg
Participants will switch from their stable baseline regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1 up to the end of randomized treatment (ERT) visit, participants will be treated for at least 24 weeks during the Randomized Period.
Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg fixed dose combination (FDC).
Bictegravir
Tablets administered orally without regard to food
Lenacapavir
Tablets administered orally without regard to food
Phase 2: BIC 75 mg + LEN 50 mg
Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1 up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period.
Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
Bictegravir
Tablets administered orally without regard to food
Lenacapavir
Tablets administered orally without regard to food
Phase 2: Stable Baseline Regimen (SBR)
Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period.
Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
Stable Baseline Regimen
SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva).
* Nucleos(t)ide Reverse Transcriptase Inhibitors:
* Abacavir
* Emtricitabine
* Lamivudine
* Tenofovir alafenamide
* Tenofovir disoproxil fumarate
* Zidovudine
* Non-Nucleosite Reverse Transcriptase Inhibitors:
* Delavirdine
* Efavirenz
* Nevirapine
* Rilpivirine
* Doravirine
* Integrase Inhibitors:
* Bictegravir
* Cabotegravir
* Dolutegravir
* Elvitegravir
* Raltegravir
* Protease Inhibitors:
* Atazanavir
* Darunavir
* Fosamprenavir
* Indinavir
* Lopinavir
* Nelfinavir
* Saquinavir
* Tipranavir
* Chemokine Co-receptor 5 (CCR5) Antagonist:
* Maraviroc
* Fusion Inhibitors:
* Enfuvirtide
* gp120 Attachment Inhibitor:
* Fostemsavir
* Anti-CD4 Monoclonal Antibodies:
* Ibalizumab-uiyk
Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC)
Participants will switch from their SBR to a regimen of BIC/LEN 75 mg/50 mg FDC. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1 up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period.
Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
BIC/LEN FDC
Tablets administered orally without regard to food
Phase 3: Stable Baseline Regimen
Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period.
Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
Stable Baseline Regimen
SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva).
* Nucleos(t)ide Reverse Transcriptase Inhibitors:
* Abacavir
* Emtricitabine
* Lamivudine
* Tenofovir alafenamide
* Tenofovir disoproxil fumarate
* Zidovudine
* Non-Nucleosite Reverse Transcriptase Inhibitors:
* Delavirdine
* Efavirenz
* Nevirapine
* Rilpivirine
* Doravirine
* Integrase Inhibitors:
* Bictegravir
* Cabotegravir
* Dolutegravir
* Elvitegravir
* Raltegravir
* Protease Inhibitors:
* Atazanavir
* Darunavir
* Fosamprenavir
* Indinavir
* Lopinavir
* Nelfinavir
* Saquinavir
* Tipranavir
* Chemokine Co-receptor 5 (CCR5) Antagonist:
* Maraviroc
* Fusion Inhibitors:
* Enfuvirtide
* gp120 Attachment Inhibitor:
* Fostemsavir
* Anti-CD4 Monoclonal Antibodies:
* Ibalizumab-uiyk
Interventions
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Bictegravir
Tablets administered orally without regard to food
Lenacapavir
Tablets administered orally without regard to food
BIC/LEN FDC
Tablets administered orally without regard to food
Stable Baseline Regimen
SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva).
* Nucleos(t)ide Reverse Transcriptase Inhibitors:
* Abacavir
* Emtricitabine
* Lamivudine
* Tenofovir alafenamide
* Tenofovir disoproxil fumarate
* Zidovudine
* Non-Nucleosite Reverse Transcriptase Inhibitors:
* Delavirdine
* Efavirenz
* Nevirapine
* Rilpivirine
* Doravirine
* Integrase Inhibitors:
* Bictegravir
* Cabotegravir
* Dolutegravir
* Elvitegravir
* Raltegravir
* Protease Inhibitors:
* Atazanavir
* Darunavir
* Fosamprenavir
* Indinavir
* Lopinavir
* Nelfinavir
* Saquinavir
* Tipranavir
* Chemokine Co-receptor 5 (CCR5) Antagonist:
* Maraviroc
* Fusion Inhibitors:
* Enfuvirtide
* gp120 Attachment Inhibitor:
* Fostemsavir
* Anti-CD4 Monoclonal Antibodies:
* Ibalizumab-uiyk
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one documented plasma 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.
* Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR), and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows:
* A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or
* A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
* A regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
* No documented or suspected resistance to bictegravir (BIC).
* Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.
Exclusion Criteria
* Active tuberculosis infection
* Chronic hepatitis B virus (HBV) infection
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
University of California San Diego (UCSD)
San Diego, California, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, United States
The Men's Health Foundation
West Hollywood, California, United States
Denver Health Medical Center
Denver, Colorado, United States
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
Therafirst Medical Centers
Fort Lauderdale, Florida, United States
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
Ft. Pierce, Florida, United States
Schiff Center for liver Diseases/University of Miami
Miami, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Therapeutic Concepts, PA
Orlando, Florida, United States
Triple O Research Institute PA
West Palm Beach, Florida, United States
Atlanta ID Group
Atlanta, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
Howard Brown Health Center
Chicago, Illinois, United States
Kansas City Care Clinic
Kansas City, Missouri, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
AXCES Research Group
Santa Fe, New Mexico, United States
New York Presbyterian Hospital
Flushing, New York, United States
Ricky K. Hsu, MD, PC
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Philadelphia FIGHT
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
Bellaire, Texas, United States
AIDS Arms, Inc., DBA Prism Health North Texas
Dallas, Texas, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States
Gordon E. Crofoot MD PA
Houston, Texas, United States
Diagnostic Clinic of Longview - Center for Clinical Research
Longview, Texas, United States
Peter Shalit, MD
Seattle, Washington, United States
Hospital General de Agudos J.M Ramon Mejia
Buenos Aires, , Argentina
Fundación Huésped
Buenos Aires, , Argentina
Helios Salud
Buenos Aires, , Argentina
St.Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Alfred Health
Melbourne, Victoria, Australia
Chronic Viral Illness Service / McGill University Health Centre (MUHC)
Decarie Montreal, , Canada
Clinique Medicale du Quartier Latin
Montreal, , Canada
The Ottawa Hospital - General Campus
Ottawa, , Canada
ID Clinic
Regina, , Canada
Maple Leaf Research
Toronto, , Canada
Spectrum Health
Vancouver, , Canada
Instituto Dominicano de Estudio Virologicos - IDEV
Santo Domingo, , Dominican Republic
CHU Nice-Hôpital l'Archet
Nice, , France
Hospital Saint Louis
Paris, , France
Groupe Hospitalier Bichat Claude Bernard
Paris, , France
Höpital de la Pitié Salpêtrière
Paris, , France
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Infektio Research GmbH & Co.KG
Frankfurt, , Germany
ICH Study Center GmbH & Co. KG
Hamburg, , Germany
MVZ München am Goetheplatz
München, , Germany
IRCCS Ospedale San Raffaele
Milan, , Italy
ASST Fatebenefratelli Sacco
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, , Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, , Italy
ASL Città di Torino
Torino, , Italy
National Hospital Organization Nagoya Medical Center
Nagoya, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, , Japan
Hope Clinical Research
San Juan, PR, Puerto Rico
Proyecto ACTU
San Juan, PR, Puerto Rico
Desmond Tutu Health Foundation Clinical Trials Unit
Cape Town, , South Africa
Sefako Makgatho Health Sciences University
Ga-Rankuwa, , South Africa
Ezintsha
Johannesburg, , South Africa
Kyungpook National University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Yonsei University Severance Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Clinic Provincial de Barcelona
Barcelona, , Spain
Hospital Ramon y Cajal, Madrid
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taoyuan General Hospital
Taoyuan, , Taiwan
Department of HIV & Sexual Medicine
Birmingham, , United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
HIV medicine and infectious diseases
London, , United Kingdom
St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre
London, , United Kingdom
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2022-500929-33
Identifier Type: OTHER
Identifier Source: secondary_id
DOH-27-052023-8574
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2051230168
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-621-6289
Identifier Type: -
Identifier Source: org_study_id
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