Clinical trial • Phase III • Infectious Disease
bictegravir, lenacapavir for HIV-1 infection
Phase III trial of bictegravir, lenacapavir for HIV-1 infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- HIV-1 infection
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 18-03-2024
- First CTIS Authorization Date
- 09-07-2024
Trial design
Randomised, biktarvy 50 mg/200 mg/25 mg film-coated tablets (emtricitabine/tenofovir alafenamide/bictegravir), oral; product record indicates maxdailydoseamount 1 (1 unit per day) — comparator arm is continuation on b/f/taf (biktarvy) as stated in trial objective.-controlled Phase III trial in France, Germany, Spain and others.
- Randomised
- Yes
- Comparator
- Biktarvy 50 mg/200 mg/25 mg film-coated tablets (emtricitabine/tenofovir alafenamide/bictegravir), oral; product record indicates maxDailyDoseAmount 1 (1 unit per day) — comparator arm is continuation on B/F/TAF (Biktarvy) as stated in trial objective.
- Target Sample Size
- 426
- Trial Duration For Participant
- 672
Eligibility
Recruits 426 Vulnerable population is selected. The protocol states: "Participants under guardianship, curatorship, or legal protection may not participate in the study." Informed consent is to be obtained using subject information and informed consent forms (ICFs) provided (multiple ICF documents listed for participating countries); consent materials are available in multiple languages as per the country-specific ICF documents..
- Pregnancy Exclusion
- Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.
- Vulnerable Population
- Vulnerable population is selected. The protocol states: "Participants under guardianship, curatorship, or legal protection may not participate in the study." Informed consent is to be obtained using subject information and informed consent forms (ICFs) provided (multiple ICF documents listed for participating countries); consent materials are available in multiple languages as per the country-specific ICF documents.
Inclusion criteria
- {"criterion_text":"- Aged ≥ 18 years at screening."}
- {"criterion_text":"- Currently receiving B/F/TAF for at least 6 months prior to screening."}
- {"criterion_text":"- If plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Plasma HIV-1 RNA levels < 50 copies/mL at screening."}
- {"criterion_text":"- No documented or suspected resistance to BIC (mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene)."}
- {"criterion_text":"- No documented or suspected resistance to tenofovir alafenamide (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)."}
- {"criterion_text":"- Estimated glomerular filtration rate > 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr)."}
- {"criterion_text":"- Participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception."}
Exclusion criteria
- {"criterion_text":"- Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization."}
- {"criterion_text":"- Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization."}
- {"criterion_text":"- Active tuberculosis infection."}
- {"criterion_text":"- Acute hepatitis < 30 days before randomization."}
- {"criterion_text":"- Chronic hepatitis B virus (HBV) infection, as determined by either: a) Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit. b) Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit."}
- {"criterion_text":"- Known hypersensitivity to the study drug, its metabolites, or any formulation excipient."}
- {"criterion_text":"- History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)."}
- {"criterion_text":"- Participants under guardianship, curatorship, or legal protection may not participate in the study."}
- {"criterion_text":"- Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator."}
- {"criterion_text":"- Active malignancy requiring acute systemic therapy."}
- {"criterion_text":"- Any of the following laboratory values at screening: a) Alanine aminotransferase > 5 × upper limit of normal (ULN) b) Direct bilirubin > 1.5 × ULN c) Platelets < 50,000/mm3 d) Hemoglobin < 8.0 g/dL"}
- {"criterion_text":"- Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3 of the protocol."}
- {"criterion_text":"- Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor."}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Breastfeeding (nursing)."}
- {"criterion_text":"- Prior use of, or exposure to, LEN."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the United States (US) Food and Drug Administration (FDA)–defined snapshot algorithm.","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48)."}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion with HIV-1 RNA < 50 copies/mL at Week 48)."}
- {"endpoint_text":"- Change from baseline in CD4 cell count at Week 48","definition_or_measurement_approach":"Change from baseline measurement of CD4 cell count at Week 48."}
- {"endpoint_text":"- Proportion of participants from Treatment Group 1 with HIV-1 RNA ≥ 50 copies/mL at Week 96 (96 weeks on BIC/LEN including blinded and open-label [OL] phases) as determined by US FDA–defined snapshot algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion with HIV-1 RNA ≥ 50 copies/mL at Week 96 for Treatment Group 1)."}
- {"endpoint_text":"- Proportion of participants from Treatment Group 1 with HIV-1 RNA < 50 copies/mL at Week 96 (96 weeks on BIC/LEN including blinded and OL phases) as determined by US FDA–defined snapshot algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion with HIV-1 RNA < 50 copies/mL at Week 96 for Treatment Group 1)."}
- {"endpoint_text":"- Change from baseline in CD4 cell count at Week 96 for participants from Treatment Group 1 (96 weeks on BIC/LEN including blinded and OL phases)","definition_or_measurement_approach":"Change from baseline measurement of CD4 cell count at Week 96 for participants in Treatment Group 1."}
- {"endpoint_text":"- Proportion of participants experiencing treatment-emergent adverse events (AEs) through Week 48","definition_or_measurement_approach":"Proportion of participants reporting treatment-emergent adverse events through Week 48."}
- {"endpoint_text":"- Proportion of participants from Treatment Group 1 experiencing treatment-emergent AEs through Week 96 (96 weeks on BIC/LEN including blinded and OL phases)","definition_or_measurement_approach":"Proportion of participants in Treatment Group 1 reporting treatment-emergent adverse events through Week 96."}
Recruitment
- Planned Sample Size
- 426
- Recruitment Window Months
- 65
- Consent Approach
- Informed consent will be obtained using subject information and informed consent forms (ICFs) provided for the study. Multiple ICF documents are listed for participating countries (e.g., Main ICFs, Pregnancy/Breastfeeding ICFs, Continuation During Pregnancy ICFs) in country-specific languages (German, French, Spanish, Italian, English). Participants are adults (≥18 years); vulnerable individuals under guardianship/curatorship/legal protection are excluded.
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 120
France
- Earliest CTIS Part Ii Submission Date
- 12-06-2024
- Latest Decision Or Authorization Date
- 21-02-2025
- Processing Time Days
- 254
- Number Of Sites
- 8
- Number Of Participants
- 30
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des maladies infectieuses et Tropicales
- Contact Person Name
- Jade Ghosn
- Contact Person Email
- jade.ghosn@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des maladies infectieuses et Tropicales
- Contact Person Name
- Nathalie De Castro
- Contact Person Email
- nathalie.de-castro@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des maladies infectieuses et Tropicales
- Contact Person Name
- Karine Lacombe
- Contact Person Email
- karine.lacombe2@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service des Maladies infectieuses et tropicales
- Contact Person Name
- Colin Deschanvres
- Contact Person Email
- colin.deschanvres@chu-nantes.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service des Maladies infectieuses et tropicales
- Contact Person Name
- Agathe Becker
- Contact Person Email
- agathe.becker@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service des maladies infectieuses et tropicales
- Contact Person Name
- Alain Makinson
- Contact Person Email
- a-makinson@chu-montpellier.fr
- Site Name
- Centre Hospitalier De Tourcoing
- Department Name
- Service Univeritaure des maladies Infectieuses et du Voyageur
- Contact Person Name
- Agnès Meybeck
- Contact Person Email
- ameybeck@ch-tourcoing.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des maladies infectieuses et Tropicales
- Contact Person Name
- Colin Deschanvres
- Contact Person Email
- colin.deschanvres@chu-nantes.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 02-07-2024
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 513
- Number Of Sites
- 8
- Number Of Participants
- 30
Sites
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- LMU Klinikum Medizinische Klinik und Poliklinik IV
- Contact Person Name
- Johannes Bogner
- Contact Person Email
- johannes.bogner@med.uni-muenchen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Studienambulanz Infektiologie
- Contact Person Name
- Olaf Degen
- Contact Person Email
- degen@uke.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin II
- Contact Person Name
- Jochen Schneider
- Contact Person Email
- jochen.schneider@tum.de
- Site Name
- Novopraxis Berlin GbR
- Contact Person Name
- Sven Schellberg
- Contact Person Email
- schellberg@novopraxis.berlin
- Site Name
- Praxis Ebertplatz
- Contact Person Name
- Christoph Wyen
- Contact Person Email
- wyen@praxis-ebertplatz.de
- Site Name
- Praxis Dr. Knechten
- Contact Person Name
- Heribert Knechten
- Contact Person Email
- hek@pzb.de
- Site Name
- Goethe University Frankfurt
- Department Name
- ZIM II, Abteilung Infektiologie
- Contact Person Name
- Christoph Stephan
- Contact Person Email
- c.stephan@em.uni-frankfurt.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- LMU Klinikum Medizinische Klinik und Poliklinik IV
- Contact Person Name
- Johannes Bogner
- Contact Person Email
- johannes.bogner@med.uni-muenchen.de
Spain
- Earliest CTIS Part Ii Submission Date
- 27-05-2024
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 547
- Number Of Sites
- 7
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- HIV Unit
- Contact Person Name
- Juan González García
- Contact Person Email
- juangonzalezgar@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- HIV Unit
- Contact Person Name
- Luis Fernando Lopez Cortés
- Contact Person Email
- luisfernando@lopezcortes.net
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Infectious Diseases
- Contact Person Name
- Alvaro Mena de Cea
- Contact Person Email
- alvaro.mena.de.cea@sergas.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Infectious Diseases
- Contact Person Name
- Josep Mallolas Masferrer
- Contact Person Email
- mallolas@clinic.cat
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- HIV Unit
- Contact Person Name
- Jose Moltó Marhuenda
- Contact Person Email
- jmolto@lluita.org
- Site Name
- Hospital General Universitario De Valencia
- Department Name
- Infectious Diseases
- Contact Person Name
- Miguel Garcia Deltoro
- Contact Person Email
- gdeltoromiguel@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Infectious Diseases
- Contact Person Name
- Santiago Moreno Guillén
- Contact Person Email
- smguillen@salud.madrid.org
Italy
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 525
- Number Of Sites
- 7
- Number Of Participants
- 30
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Infectious and Tropical Diseases Unit
- Contact Person Name
- Emanuele Focà
- Contact Person Email
- emanuele.foca@unibs.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unit of Infectious Diseases
- Contact Person Name
- Antonella Castagna
- Contact Person Email
- castagna.antonella@hsr.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- sergio.locaputo@unifg.it
- Contact Person Name
- Sergio Lo Caputo
- Contact Person Email
- sergio.locaputo@unifg.it
- Site Name
- National Institute For Infectious Diseases Lazzaro Spallanzani
- Department Name
- Viral Immunodeficiencies Unit
- Contact Person Name
- Andrea Antinori
- Contact Person Email
- andrea.antinori@inmi.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- S.C. Malattie Infettive
- Contact Person Name
- Paolo Bonfanti
- Contact Person Email
- paolo.bonfanti@unimib.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- SC Malattie Infettive I
- Contact Person Name
- Roberto Gulminetti
- Contact Person Email
- r.gulminetti@smatteo.pv.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Unità Operativa di Malattie Infettive
- Contact Person Name
- Simona Di Giambenedetto
- Contact Person Email
- simona.digiambenedetto@policlinicogemelli.it
Sponsor
Primary sponsor
- Full Name
- Gilead Sciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- FSP Site Contract Negotiations
- Name
- PPD Development L.P.
- Responsibilities
- Codes: 1,12,13,2,5 (as listed in sponsor duties)
- Name
- Labcorp Drug Development Inc.
- Responsibilities
- Central Labs and Bioanalytical analysis Laboratory analysis
- Name
- QPS LLC
- Responsibilities
- BioAnalysis in human plasma Laboratory analysis
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"15: FSP Site Contract Negotiations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development L.P.","duties_or_roles":"1,12,13,2,5","organisation_type":"Industry"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Monogram Biosciences Inc.","duties_or_roles":"15: Virology-whole blood clinical sample assay (Genosure testing ) Laboratory analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"15: BioAnalysis in human plasma Laboratory analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Institute of Immunology and Genetics","duties_or_roles":"15: Virology-plasma clinical sample assay (analysisGenosure, PhenoSense GT, PhenoSense Integrase, GeneSeq) Laboratory analysis","organisation_type":"Health care"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Drug Development Inc.","duties_or_roles":"15: Central Labs and Bioanalytical analysis Laboratory analysis","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- BICTEGRAVIR 75 MG/LENACAPAVIR 50 MG FDC TABLETS
- Active Substance
- bictegravir, lenacapavir
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Starting Dose
- BIC 75 mg / LEN 50 mg (FDC tablet)
- Frequency
- 1 tablet daily (as per product record: maxDailyDoseAmount 1)
- Investigational Product Name
- Sunlenca 300 mg film-coated tablets
- Active Substance
- lenacapavir
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- EU/1/22/1671/001
- Starting Dose
- Sunlenca 300 mg film-coated tablets
- Maximum Dose
- 600 mg (maxDailyDoseAmount 600 mg as per product record)
- Investigational Product Name
- Biktarvy 50 mg/200 mg/25 mg film-coated tablets
- Active Substance
- emtricitabine, tenofovir alafenamide, bictegravir
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- EU/1/18/1289/001
- Starting Dose
- Biktarvy 50 mg/200 mg/25 mg, 1 tablet daily
- Frequency
- 1 tablet daily (maxDailyDoseAmount 1)
- Investigational Product Name
- PTM 300 mg tablets
- Modality
- Other
- Investigational Product Name
- PTM 75/50 mg FDC tablets
- Modality
- Other
- Investigational Product Name
- PTM 50/200/25 mg FDC tablets
- Modality
- Other
- Combination Treatment
- Yes
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