Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
- Conditions
- HIV-1-infection
- Interventions
- Registration Number
- NCT05502341
- 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) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 689
-
If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL.
-
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.
Key
- Prior use of, or exposure to, lenacapavir (LEN)
- Active tuberculosis infection
- Chronic hepatitis B virus (HBV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 2: Stable Baseline Regimen (SBR) Stable Baseline Regimen 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. Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC) BIC/LEN 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. Phase 3: Stable Baseline Regimen 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. Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg Lenacapavir 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). Phase 2: BIC 75 mg + LEN 50 mg Lenacapavir 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. Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg Bictegravir 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). Phase 2: BIC 75 mg + LEN 50 mg Bictegravir 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.
- Primary Outcome Measures
Name Time Method Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm Week 24 Phase 3: 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 Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm Week 24 Phase 2: Change From Baseline in CD4 Cell Count at Week 24 Baseline, Week 24 Phase 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (AEs) Through Week 24 First dose date up to Week 24 Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir (BIC) and Lenacapavir (LEN) at Steady State Day 1 up to Week 24 Cmax is defined as the maximum observed concentration of drug.
Phase 3 (BIC/LEN 75 mg/50 mg FDC): Proportion of Participants from Experiencing Treatment-emergent AEs Through Week 96 Week 96 Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State Day 1 up to Week 24 AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Phase 2: PK Parameter: Ctau of BIC and LEN at Steady State Day 1 up to Week 24 Ctau is defined as the observed drug concentration at the end of the dosing interval.
Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm Week 48 Phase 3: Change From Baseline in CD4 Cell Count at Week 48 Baseline, Week 48 Phase 3 (BIC/LEN 75 mg/50 mg FDC): Proportion of Participants from With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm Week 96 Phase 3 (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96 Baseline, Week 96 Phase 3: Percentage of Participants Experiencing Treatment-emergent AEs Through Week 48 First dose date up to Week 48
Trial Locations
- Locations (93)
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hope Clinical Research
🇵🇷San Juan, Puerto Rico
Proyecto ACTU
🇵🇷San Juan, 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
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
🇪🇸Sevilla, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
Taoyuan General Hospital
🇨🇳Taoyuan City, 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
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
🇺🇸Fort Pierce, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Schiff Center for liver Diseases/University of Miami
🇺🇸Miami, 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.
🇺🇸Saint 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 Cedex 03, France
Höpital de la Pitié Salpêtrière
🇫🇷Paris Cedex 13, France
Hospital Saint Louis
🇫🇷Paris, France
Groupe Hospitalier Bichat Claude Bernard
🇫🇷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
🇮🇹Milano, Italy
ASST Fatebenefratelli Sacco
🇮🇹Milano, 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
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of