多剤耐性を伴う HIV-1 感染症に罹患している重度の治療経験のある参加者における、最適化されたバックグラウンドレジメン (OBR) と組み合わせたレナカパビル (GS-6207) の安全性と有効性を評価するための研究 (CAPELLA)
重度の治療経験があり、多剤耐性を有する HIV-1 感染症患者を対象に、最適化されたバックグラウンドレジメンと組み合わせた長時間作用型カプシド阻害剤 GS-6207 の安全性と有効性を評価する第 2/3 相試験
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).
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90036
- Ruane Clinical Research Group Inc
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Los Angeles、California、アメリカ、90069
- Mills Clinical Research
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Palm Springs、California、アメリカ、92264
- Eisenhower Health Center at Rimrock
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Sacramento、California、アメリカ、95817
- One Community Health
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Connecticut
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New Haven、Connecticut、アメリカ、06510
- Yale University; School of Medicine
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District of Columbia
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Washington D.C.、District of Columbia、アメリカ、20017
- Washington Health Institute
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Florida
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DeLand、Florida、アメリカ、32720
- Midland Florida Clinical Research Center, LLC
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Fort Lauderdale、Florida、アメリカ、33316
- Gary J. Richmond, M.D., P.A.
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Ft. Pierce、Florida、アメリカ、34982
- Midway Immunology and Research Center
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Hialeah、Florida、アメリカ、33016
- Floridian Clinical Research
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Miami Beach、Florida、アメリカ、33139
- AIDS Healthcare Foundation - South Beach
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Orlando、Florida、アメリカ、32803
- Orlando Immunology Center
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Tampa、Florida、アメリカ、33614
- St. Joseph's Hospital Comprehensive Research Institute
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West Palm Beach、Florida、アメリカ、33401
- Triple O Research Institute, P.A.
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Georgia
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Atlanta、Georgia、アメリカ、30309
- Atlanta ID Group, PC
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Atlanta、Georgia、アメリカ、30308
- Emory Hospital Midtown Infectious Disease Clinic
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Savannah、Georgia、アメリカ、31401
- Chatham County Health Department
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Illinois
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Chicago、Illinois、アメリカ、60613
- Howard Brown Health Center
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Chicago、Illinois、アメリカ、60657
- Northstar Healthcare
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Michigan
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Berkley、Michigan、アメリカ、48072
- Be Well Medical Center
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Missouri
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St Louis、Missouri、アメリカ、63139
- Southampton Healthcare, Inc.
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New York
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Flushing、New York、アメリカ、11355
- New York-Presbyterian/Queens
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Manhasset、New York、アメリカ、11030
- North Shore University Hospital/Division of Infectious Diseases
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The Bronx、New York、アメリカ、10461
- Jacobi Medical Center
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North Carolina
-
Charlotte、North Carolina、アメリカ、28209
- Atrium Health- Infectious Disease Consultants
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-
Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、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、アメリカ、02906
- The Miriam Hospital
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Tennessee
-
Memphis、Tennessee、アメリカ、38163
- 1265 Union Avenue, 8 East
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-
Texas
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Austin、Texas、アメリカ、78705
- Central Texas Clinical Research
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Bellaire、Texas、アメリカ、77401
- St Hope Foundation
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Dallas、Texas、アメリカ、75246
- North Texas Infectious Diseases Consultants, P.A.
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Dallas、Texas、アメリカ、75215
- AIDS Arms, Inc. DBA Prism Health North Texas
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Houston、Texas、アメリカ、77098
- The Crofoot Research Center, INC.
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Longview、Texas、アメリカ、75605
- DCOL Center for Clinical Research
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Virginia
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Annandale、Virginia、アメリカ、22003
- Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
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-
-
-
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Bergamo、イタリア、24127
- University of Naples Federico II
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Brescia、イタリア、25100
- UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
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Milan、イタリア、20127
- Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
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Roma、イタリア、00149
- U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
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Rome、イタリア、00168
- U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
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Ottawa、カナダ、K1H 8L6
- The Ottawa Hospital
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British Columbia
-
Vancouver、British Columbia、カナダ、V6Z 2C9
- Vancouver ID Research and Care Centre Society
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Ontario
-
Toronto、Ontario、カナダ、M5G 1K2
- Maple Leaf Research/Maple Leaf Medical Clinic
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Quebec
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Montreal、Quebec、カナダ、H2L 4E9
- Clinique de médecine urbaine du Quartier Latin
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-
-
-
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Badalona、スペイン、08916
- Hospital Universitari Germans Trías i Pujol
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Barcelona、スペイン、08036
- Hospital Clinic de Barcelona
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Madrid、スペイン、28046
- Hospital Universitario La Paz
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Seville、スペイン、41013
- Hospital Universitario Virgen del Rocío
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-
-
-
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Bangkok、タイ、10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
-
Bangkok、タイ、10400
- Faculty of Medicine Ramathibodi Hospital, Mahidol University
-
Bangkok、タイ、10330
- Thai Red Cross AIDS Research Center
-
Khon Kaen、タイ、40002
- Faculty of Medicine, Khon Kaen University
-
Nonthaburi、タイ、11000
- Bamrasnaradura Infectious Diseases Institute
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-
-
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Essen、ドイツ、45122
- Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
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Hamburg、ドイツ、20146
- ICH Study Center GmbH & Co. KG
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Hesse
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Frankfurt am Main、Hesse、ドイツ、60590
- Universitätsklinikum Frankfurt, Medizinische Klinik II
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Santo Domingo、ドミニカ共和国、10103
- Instituto Dominicano de Estudios Virologicos (IDEV)
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Santo Domingo、ドミニカ共和国、10514
- Hospital Dr. Salvador Bienvenido Gautier
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Marseille、フランス、13009
- Hôpital Sainte-Marguerite
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Paris、フランス、75012
- Hôpital Saint-Antoine
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Paris、フランス、75018
- Hôpital Bichat-Claude Bernard
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Paris、フランス、75010
- Hôpital Saint-Louis
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Durban、南アフリカ、4302
- Durban International Clinical Research Site, Enhancing Care Foundation
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Johannesburg、南アフリカ、2092
- Helen Joseph Hospital
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Pretoria、南アフリカ、87
- Vx Pharma
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Soweto、南アフリカ、2013
- Perinatal HIV Research Unit (PHRU)
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Kaohsiung City、台湾、81362
- Kaohsiung Veterans General Hospital
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Kaohsiung City、台湾、80756
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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New Taipei City、台湾、22060
- Far Eastern Memorial Hospital
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Taipei、台湾、10048
- National Taiwan University Hospital
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Taoyuan City、台湾、33004
- Taoyuan General Hospital, Ministry of Health and Welfare
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Nagoya、日本、460-0001
- National Hospital Organization Nagoya Medical Center
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Osaka、日本、540-0006
- National Hospital Organization Osaka National Hospital
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Tokyo、日本、1600023
- Tokyo Medical University Hospital
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Tokyo、日本、1628655
- Center Hospital of the National Center for Global Health and Medicine
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
Administered in the abdomen via subcutaneous injections
他の名前：
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 |
|
プラセボコンパレーター：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
他の名前：
Administered in the abdomen via subcutaneous injections
他の名前：
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 |
|
実験的：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
他の名前：
Administered in the abdomen via subcutaneous injections
他の名前：
Optimized background regimen as prescribed by the Investigator |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
コホート 1 の参加者の割合 ヒト免疫不全ウイルス 1 リボ核酸 (HIV-1 RNA) の ≥ 0.5 log10 コピー/mL の減少をベースラインから機能的単剤療法期間の終了まで達成
時間枠：SC訪問1日目までのベースライン（経口レンカパビルの初回投与から14日後）または15日目
|
SC訪問1日目までのベースライン（経口レンカパビルの初回投与から14日後）または15日目
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
|
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)
|
|
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
時間枠：Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
|
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)
|
|
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
時間枠：Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
|
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)
|
|
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
時間枠：Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
|
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)
|
|
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
時間枠：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 < 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)
|
|
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
時間枠：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)
|
|
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
時間枠：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 < 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)
|
|
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
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Gilead Study Director、Gilead Sciences
出版物と役立つリンク
一般刊行物
- 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.
- Ogbuagu O, Molina JM, Chetchotisakd P, Ramgopal MN, Sanchez W, Brunetta J, Castelli F, Crofoot GE, Hung CC, Ronot-Bregigeon S, Margot NA, Wang H, Dvory-Sobol H, Rhee MS, Segal-Maurer S. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial. Clin Infect Dis. 2025 Mar 17;80(3):566-574. doi: 10.1093/cid/ciae423.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GS-US-200-4625
- 2019-003814-16 (EudraCT番号)
- 2019 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。