Studie k vyhodnocení bezpečnosti a účinnosti lenacapaviru (GS-6207) v kombinaci s optimalizovaným základním režimem (OBR) u zkušených účastníků těžké léčby žijících s infekcí HIV-1 s multirezistencí (CAPELLA)
Studie fáze 2/3 k vyhodnocení bezpečnosti a účinnosti dlouhodobě působícího kapsidového inhibitoru GS-6207 v kombinaci s optimalizovaným základním režimem při těžké léčbě Zkušení lidé žijící s infekcí HIV-1 s multirezistencí
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní místa
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Santo Domingo, Dominikánská republika, 10103
- Instituto Dominicano de Estudios Virologicos (IDEV)
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Santo Domingo, Dominikánská republika, 10514
- Hospital Dr. Salvador Bienvenido Gautier
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Marseille, Francie, 13009
- Hôpital Sainte-Marguerite
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Paris, Francie, 75012
- Hôpital Saint-Antoine
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Paris, Francie, 75018
- Hôpital Bichat-Claude Bernard
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Paris, Francie, 75010
- Hôpital Saint-Louis
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Bergamo, Itálie, 24127
- University of Naples Federico II
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Brescia, Itálie, 25100
- UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
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Milan, Itálie, 20127
- Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
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Roma, Itálie, 00149
- U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
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Rome, Itálie, 00168
- U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
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Nagoya, Japonsko, 460-0001
- National Hospital Organization Nagoya Medical Center
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Osaka, Japonsko, 540-0006
- National Hospital Organization Osaka National Hospital
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Tokyo, Japonsko, 1600023
- Tokyo Medical University Hospital
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Tokyo, Japonsko, 1628655
- Center Hospital of the National Center for Global Health and Medicine
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Durban, Jižní Afrika, 4302
- Durban International Clinical Research Site, Enhancing Care Foundation
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Johannesburg, Jižní Afrika, 2092
- Helen Joseph Hospital
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Pretoria, Jižní Afrika, 87
- Vx Pharma
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Soweto, Jižní Afrika, 2013
- Perinatal HIV Research Unit (PHRU)
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Ottawa, Kanada, K1H 8L6
- The Ottawa Hospital
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British Columbia
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Vancouver, British Columbia, Kanada, V6Z 2C9
- Vancouver ID Research and Care Centre Society
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Ontario
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Toronto, Ontario, Kanada, M5G 1K2
- Maple Leaf Research/Maple Leaf Medical Clinic
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Quebec
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Montreal, Quebec, Kanada, H2L 4E9
- Clinique de médecine urbaine du Quartier Latin
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Essen, Německo, 45122
- Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
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Hamburg, Německo, 20146
- ICH Study Center GmbH & Co. KG
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Hesse
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Frankfurt am Main, Hesse, Německo, 60590
- Universitätsklinikum Frankfurt, Medizinische Klinik II
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California
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Los Angeles, California, Spojené státy, 90036
- Ruane Clinical Research Group Inc
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Los Angeles, California, Spojené státy, 90069
- Mills Clinical Research
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Palm Springs, California, Spojené státy, 92264
- Eisenhower Health Center at Rimrock
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Sacramento, California, Spojené státy, 95817
- One Community Health
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Connecticut
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New Haven, Connecticut, Spojené státy, 06510
- Yale University; School of Medicine
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District of Columbia
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Washington D.C., District of Columbia, Spojené státy, 20017
- Washington Health Institute
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Florida
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DeLand, Florida, Spojené státy, 32720
- Midland Florida Clinical Research Center, LLC
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Fort Lauderdale, Florida, Spojené státy, 33316
- Gary J. Richmond, M.D., P.A.
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Ft. Pierce, Florida, Spojené státy, 34982
- Midway Immunology and Research Center
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Hialeah, Florida, Spojené státy, 33016
- Floridian Clinical Research
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Miami Beach, Florida, Spojené státy, 33139
- AIDS Healthcare Foundation - South Beach
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Orlando, Florida, Spojené státy, 32803
- Orlando Immunology Center
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Tampa, Florida, Spojené státy, 33614
- St. Joseph's Hospital Comprehensive Research Institute
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West Palm Beach, Florida, Spojené státy, 33401
- Triple O Research Institute, P.A.
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Georgia
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Atlanta, Georgia, Spojené státy, 30309
- Atlanta ID Group, PC
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Atlanta, Georgia, Spojené státy, 30308
- Emory Hospital Midtown Infectious Disease Clinic
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Savannah, Georgia, Spojené státy, 31401
- Chatham County Health Department
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Illinois
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Chicago, Illinois, Spojené státy, 60613
- Howard Brown Health Center
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Chicago, Illinois, Spojené státy, 60657
- Northstar Healthcare
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Michigan
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Berkley, Michigan, Spojené státy, 48072
- Be Well Medical Center
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Missouri
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St Louis, Missouri, Spojené státy, 63139
- Southampton Healthcare, Inc.
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New York
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Flushing, New York, Spojené státy, 11355
- New York-Presbyterian/Queens
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Manhasset, New York, Spojené státy, 11030
- North Shore University Hospital/Division of Infectious Diseases
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The Bronx, New York, Spojené státy, 10461
- Jacobi Medical Center
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28209
- Atrium Health- Infectious Disease Consultants
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02906
- The Miriam Hospital
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Tennessee
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Memphis, Tennessee, Spojené státy, 38163
- 1265 Union Avenue, 8 East
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Texas
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Austin, Texas, Spojené státy, 78705
- Central Texas Clinical Research
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Bellaire, Texas, Spojené státy, 77401
- St Hope Foundation
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Dallas, Texas, Spojené státy, 75246
- North Texas Infectious Diseases Consultants, P.A.
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Dallas, Texas, Spojené státy, 75215
- AIDS Arms, Inc. DBA Prism Health North Texas
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Houston, Texas, Spojené státy, 77098
- The Crofoot Research Center, INC.
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Longview, Texas, Spojené státy, 75605
- DCOL Center for Clinical Research
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Virginia
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Annandale, Virginia, Spojené státy, 22003
- Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
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Kaohsiung City, Tchaj-wan, 81362
- Kaohsiung Veterans General Hospital
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Kaohsiung City, Tchaj-wan, 80756
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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New Taipei City, Tchaj-wan, 22060
- Far Eastern Memorial Hospital
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Taipei, Tchaj-wan, 10048
- National Taiwan University Hospital
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Taoyuan City, Tchaj-wan, 33004
- Taoyuan General Hospital, Ministry of Health and Welfare
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Bangkok, Thajsko, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
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Bangkok, Thajsko, 10400
- Faculty of Medicine Ramathibodi Hospital, Mahidol University
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Bangkok, Thajsko, 10330
- Thai Red Cross AIDS Research Center
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Khon Kaen, Thajsko, 40002
- Faculty of Medicine, Khon Kaen University
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Nonthaburi, Thajsko, 11000
- Bamrasnaradura Infectious Diseases Institute
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Badalona, Španělsko, 08916
- Hospital Universitari Germans Trías i Pujol
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Barcelona, Španělsko, 08036
- Hospital Clinic de Barcelona
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Madrid, Španělsko, 28046
- Hospital Universitario La Paz
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Seville, Španělsko, 41013
- Hospital Universitario Virgen del Rocío
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Key Inclusion Criteria:
- Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)
- Currently receiving a stable failing ARV regimen for > 8 weeks
- Have HIV-1 RNA ≥ 400 copies/mL at screening
- Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV)
- Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen
- Able and willing to receive an OBR together with lenacapavir
- No Hepatitis C virus (HCV) ongoing infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: Cohort 1A: Lenacapavir
Participants with HIV-1 ribonucleic acid (RNA) ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at Cohort Selection visit compared with screening visit will receive oral lenacapavir (LEN) 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen in the blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive subcutaneous (SC) LEN 927 mg and will initiate an optimized background regimen (OBR) at Day 1 SC Visit (14 days after the first dose of oral LEN). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country. |
Tablets administered without regard to food
Ostatní jména:
Administered in the abdomen via subcutaneous injections
Ostatní jména:
Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen. Optimized background regimen as prescribed by the Investigator |
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Komparátor placeba: Cohort 1B: Placebo to Lenacapavir
Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit will receive oral LEN placebo on Days 1, 2, and 8 while continuing their failing regimen in the blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive oral LEN 600 mg on Days 15 and 16 and 300 mg on Day 22, and will initiate an OBR on Day 15. At Day 1 SC (14 days after the first dose of oral LEN), participants will receive SC LEN 927 mg while continuing OBR. At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country. |
Tablets administered without regard to food
Ostatní jména:
Administered in the abdomen via subcutaneous injections
Ostatní jména:
Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen. Optimized background regimen as prescribed by the Investigator Tablets administered without regard to food |
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Experimentální: Cohort 2: Lenacapavir
Participants with a ≥ 0.5 log10 copies/mL HIV-1 RNA decline at the Cohort Selection Visit compared with the screening visit or with HIV-1 RNA < 400 copies/mL or if Cohort 1 is fully enrolled will receive oral LEN 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants will receive SC LEN 927 mg at Day 1 SC Visit (14 days after the first dose of oral LEN) while continuing their OBR. At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country. |
Tablets administered without regard to food
Ostatní jména:
Administered in the abdomen via subcutaneous injections
Ostatní jména:
Optimized background regimen as prescribed by the Investigator |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Procento účastníků v kohortě 1, kteří dosáhli snížení ≥ 0,5 log10 kopií/ml ribonukleové kyseliny viru lidské imunodeficience-1 (HIV-1 RNA) od výchozího stavu do konce období funkční monoterapie
Časové okno: Výchozí stav do dne 1 SC návštěvy (14 dní po první dávce perorálního lencapaviru) nebo dne 15
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Výchozí stav do dne 1 SC návštěvy (14 dní po první dávce perorálního lencapaviru) nebo dne 15
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm
Časové okno: Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
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The percentage of participants in cohort 1 with plasma HIV-1 RNA < 50 copies/mL at Week 26 was analyzed using the United States Food and Drug Administration (US FDA)-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
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Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm
Časové okno: Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
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The percentage of participants in cohort 1 with plasma HIV-1 RNA < 200 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
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Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm
Časové okno: Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
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The percentage of participants in cohort 1 with plasma HIV-1 RNA < 50 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off. |
Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
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Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm
Časové okno: Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
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The percentage of participants in cohort 1 with plasma HIV-1 RNA < 200 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off. |
Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
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Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm
Časové okno: Week 104 (104 weeks after first dose of subcutaneous lenacapavir)
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The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 50 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off. |
Week 104 (104 weeks after first dose of subcutaneous lenacapavir)
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Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm
Časové okno: Week 104 (104 weeks after first dose of subcutaneous lenacapavir)
|
The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 200 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off. |
Week 104 (104 weeks after first dose of subcutaneous lenacapavir)
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Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm
Časové okno: Week 156 (156 weeks after first dose of subcutaneous lenacapavir)
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The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 50 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off. |
Week 156 (156 weeks after first dose of subcutaneous lenacapavir)
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Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm
Časové okno: Week 156 (156 weeks after first dose of subcutaneous lenacapavir)
|
The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 200 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off. |
Week 156 (156 weeks after first dose of subcutaneous lenacapavir)
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Gilead Study Director, Gilead Sciences
Publikace a užitečné odkazy
Obecné publikace
- Segal-Maurer S, Castagna A, Berhe M, et al. Potent Antiviral Activity of Lenacapavir in Phase 2/3 in Heavily ART-Experienced PWH [Abstract 127]. Presented at: Conference on Retroviruses and Opportunistic Infections; 2021 March 6-10.
- Ogbuagu O, Ratanasuwan W, Avihingsanon A, Chetchotisakd P, Wiznia A, Kimberly W, et al. Lenacapavir Efficacy in CAPELLA Patients with No Fully Active Agents in Optimized Background Regimen. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI), 2024 March 3-6
- Margot N, Pennetzdorfer N, Naik V, Rhee M, Callebaut C. Cross-resistance to entry inhibitors and lenacapavir resistance through Week 52 in study CAPELLA. Antivir Ther. 2023 Dec;28(6):13596535231220754. doi: 10.1177/13596535231220754.
- Castagna A, Blanco Arevalo JL, Molina JM, Antinori A, Castelli F, Yazdanpanah Y, et al. Follow-Up of Injection Site Reactions in Clinical Studies of People Using Lenacapavir Every 6 Months for HIV Treatment [Poster eP.A.104]. Presented at: European AIDS Conference (EACS), 2023 October 18-21
- Margot N, Jogiraju V, VanderVeen L, Naik V, Dvory-Sobol H, Rhee MS, et al. Resistance Analysis of Long-Acting Lenacapavir in Heavily Treatment-Experienced People with HIV after 104 Weeks of Treatment [PS8 O4]. Presented at: European AIDS Conference (EACS), 2023 18-21 October
- Ogbuagu O, DeJesus E, Berhe M, Richmond GJ, Ruane PJ, Sinclair GI, et al. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multi-Drug Resistant HIV: Week 104 Results [Poster 1596]. Presented at: IDWeek, 2023 11-15 October
- Ogbuagu O, Segal-Maurer S, Ratanasuwan W, Avihingsanon A, Brinson C, Workowski K, Antinori A, Yazdanpanah Y, Trottier B, Wang H, Margot N, Dvory-Sobol H, Rhee MS, Baeten JM, Molina JM; GS-US-200-4625 investigators. Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial. Lancet HIV. 2023 Aug;10(8):e497-e505. doi: 10.1016/S2352-3018(23)00113-3. Epub 2023 Jul 11.
- Ogbuagu O, Avihingsanon A, Segal-Maurer S, Wang H, Rhee MS, Dvory-Sobol H, et al. Lenacapavir Oral Bridging (300 mg QW) Maintains Efficacy with a Similar Safety Profile When SC LEN Cannot Be Administered [Oral OAB0205] Presented at:12th International AIDS Society (IAS) Conference on HIV Science, 2023 23-26 July.
- Margot NA, Naik V, VanderVeen L, Anoshchenko O, Singh R, Dvory-Sobol H, Rhee MS, Callebaut C. Resistance Analyses in Highly Treatment-Experienced People With Human Immunodeficiency Virus (HIV) Treated With the Novel Capsid HIV Inhibitor Lenacapavir. J Infect Dis. 2022 Nov 28;226(11):1985-1991. doi: 10.1093/infdis/jiac364.
- Antinori A, Castelli F, Ronot-Bregigeon S, Yazdanpanah Y, Safran R, S. Berger DS, et al. Common Adverse Events in Clinical Studies of People Using Lenacapavir for HIV Treatment [P027]. Presented at: HIV Glasgow 2022, October 23-26
- Ogbuagu O, Segal-Maurer S, Ratanasuwan W, Trottier B,4 Brunetta J, Shirasaka T, et al. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People With Multi-Drug Resistant HIV: Week 52 Results [Oral 1585]. Presented at: IDWeek 2022, October 19-23
- Castagna A, J Blanco JL, Hung CC, Rassool M, Ramgopal MN, Sanchez W, et al. Week 52 Subgroup Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People With Multidrug-Resistant HIV (CAPELLA Study) [P026]. Presented at: HIV Glasgow, 2022 October 23-26
- Kumar P, Gupta S, Segal-Maurer S, Ogbuagu O, McDonald C, Brinson C, et al. Injection-Site Reaction Experience in Clinical Studies of People Using Lenacapavir For HIV Treatment [Poster EPB184]. Presented at: AIDS, 2022 29 July-2 August
- Segal-Maurer S, DeJesus E, Stellbrink HJ, Castagna A, Richmond GJ, Sinclair GI, Siripassorn K, Ruane PJ, Berhe M, Wang H, Margot NA, Dvory-Sobol H, Hyland RH, Brainard DM, Rhee MS, Baeten JM, Molina JM; CAPELLA Study Investigators. Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2022 May 12;386(19):1793-1803. doi: 10.1056/NEJMoa2115542.
- Margot N, Laurie VanderVeen L, Naik V, Chang S, Parvangada PC, Martin R, et al. Resistance Analysis of Long-Acting Lenacapavir in Highly Treatment-Experienced People with HIV After 26 Weeks of Treatment [Oral OS1/1]. Presented at: European AIDS Conference (EACS); 2021 October 27-30
- Stellbrink HJ, DeJesus E, Segal-Maurer S, Castagna A, Avihingsanon A, Blanco Arevalo JL, et al. Subgroups Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People with HIV (CAPELLA study) [Abstract PE2/69]. Presented at: European AIDS Conference (EACS); 2021 October 27-30
- Segal-Maurer S, Castagna A, Berhe M, et al. Potent Antiviral Activity of Lenacapavir in Phase 2/3 in Heavily ART-Experienced PWH [Abstract 127]. Presented at: Conference on Retroviruses and Opportunistic Infections; 2021 March 6-10
- Ogbuagu O, Wiznia A, McGowan JP, Berger DS, Creticos CM, Hagins D, Hodge T, Osiyemi O, Sims J, Wheeler DA, Wang H, Margot NA, Dvory-Sobol H, Rhee MS, Segal-Maurer S, Molina JM. Subcutaneous Lenacapavir in People With Multidrug-Resistant HIV-1: 156 Week Results of the CAPELLA Study. Open Forum Infect Dis. 2025 Dec 19;13(1):ofaf763. doi: 10.1093/ofid/ofaf763. eCollection 2026 Jan.
- Margot NA, Jogiraju V, Pennetzdorfer N, Naik V, VanderVeen LA, Ling J, Singh R, Dvory-Sobol H, Ogbuagu O, Segal-Maurer S, Molina JM, Rhee MS, Callebaut C. Resistance Analyses in Heavily Treatment-Experienced People With HIV Treated With the Novel HIV Capsid Inhibitor Lenacapavir After 2 Years. J Infect Dis. 2025 Jun 2;231(5):1239-1245. doi: 10.1093/infdis/jiaf050.
- Ogbuagu OE, Avihingsanon A, Segal-Maurer S, Wang H, Jogiraju VK, Singh R, Rhee MS, Dvory-Sobol H, Sklar PA, Molina JM. Efficacy, safety, and pharmacokinetics of lenacapavir oral bridging when subcutaneous lenacapavir cannot be administered. AIDS. 2025 May 1;39(6):639-648. doi: 10.1097/QAD.0000000000004142. Epub 2025 Feb 10.
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Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- GS-US-200-4625
- 2019-003814-16 (Číslo EudraCT)
- 2019 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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