NCT04150068

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
8mo left

Started Nov 2019

Longer than P75 for phase_2

Geographic Reach
11 countries

75 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Nov 2019Jan 2027

First Submitted

Initial submission to the registry

October 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 20, 2021

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

March 13, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

October 28, 2019

Results QC Date

September 28, 2021

Last Update Submit

February 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period

    Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15

Secondary Outcomes (8)

  • 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

    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

    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

    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

    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

    Week 104 (104 weeks after first dose of subcutaneous lenacapavir)

  • +3 more secondary outcomes

Study Arms (3)

Cohort 1A: Lenacapavir

EXPERIMENTAL

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.

Drug: Oral LenacapavirDrug: Subcutaneous LenacapavirDrug: Failing ARV RegimenDrug: Optimized Background Regimen (OBR)

Cohort 1B: Placebo to Lenacapavir

PLACEBO COMPARATOR

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.

Drug: Oral LenacapavirDrug: Oral Lenacapavir PlaceboDrug: Subcutaneous LenacapavirDrug: Failing ARV RegimenDrug: Optimized Background Regimen (OBR)

Cohort 2: Lenacapavir

EXPERIMENTAL

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.

Drug: Oral LenacapavirDrug: Subcutaneous LenacapavirDrug: Optimized Background Regimen (OBR)

Interventions

Tablets administered without regard to food

Also known as: Sunlenca®, GS-6207
Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: Lenacapavir

Tablets administered without regard to food

Cohort 1B: Placebo to Lenacapavir

Administered in the abdomen via subcutaneous injections

Also known as: Sunlenca®, GS-6207
Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: Lenacapavir

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.

Cohort 1A: LenacapavirCohort 1B: Placebo to Lenacapavir

Optimized background regimen as prescribed by the Investigator

Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: Lenacapavir

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (75)

Ruane Clinical Research Group Inc

Los Angeles, California, 90036, United States

Location

Mills Clinical Research

Los Angeles, California, 90069, United States

Location

Eisenhower Health Center at Rimrock

Palm Springs, California, 92264, United States

Location

One Community Health

Sacramento, California, 95817, United States

Location

Yale University; School of Medicine

New Haven, Connecticut, 06510, United States

Location

Washington Health Institute

Washington D.C., District of Columbia, 20017, United States

Location

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720, United States

Location

Gary J. Richmond, M.D., P.A.

Fort Lauderdale, Florida, 33316, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

Floridian Clinical Research

Hialeah, Florida, 33016, United States

Location

AIDS Healthcare Foundation - South Beach

Miami Beach, Florida, 33139, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

St. Joseph's Hospital Comprehensive Research Institute

Tampa, Florida, 33614, United States

Location

Triple O Research Institute, P.A.

West Palm Beach, Florida, 33401, United States

Location

Emory Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, 30308, United States

Location

Atlanta ID Group, PC

Atlanta, Georgia, 30309, United States

Location

Chatham County Health Department

Savannah, Georgia, 31401, United States

Location

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

Northstar Healthcare

Chicago, Illinois, 60657, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

Southampton Healthcare, Inc.

St Louis, Missouri, 63139, United States

Location

New York-Presbyterian/Queens

Flushing, New York, 11355, United States

Location

North Shore University Hospital/Division of Infectious Diseases

Manhasset, New York, 11030, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Atrium Health- Infectious Disease Consultants

Charlotte, North Carolina, 28209, United States

Location

Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

1265 Union Avenue, 8 East

Memphis, Tennessee, 38163, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

St Hope Foundation

Bellaire, Texas, 77401, United States

Location

AIDS Arms, Inc. DBA Prism Health North Texas

Dallas, Texas, 75215, United States

Location

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas, 75246, United States

Location

The Crofoot Research Center, INC.

Houston, Texas, 77098, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)

Annandale, Virginia, 22003, United States

Location

Vancouver ID Research and Care Centre Society

Vancouver, British Columbia, V6Z 2C9, Canada

Location

Maple Leaf Research/Maple Leaf Medical Clinic

Toronto, Ontario, M5G 1K2, Canada

Location

Clinique de médecine urbaine du Quartier Latin

Montreal, Quebec, H2L 4E9, Canada

Location

The Ottawa Hospital

Ottawa, K1H 8L6, Canada

Location

Instituto Dominicano de Estudios Virologicos (IDEV)

Santo Domingo, 10103, Dominican Republic

Location

Hospital Dr. Salvador Bienvenido Gautier

Santo Domingo, 10514, Dominican Republic

Location

Hôpital Sainte-Marguerite

Marseille, 13009, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

Universitätsklinikum Frankfurt, Medizinische Klinik II

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie

Essen, 45122, Germany

Location

ICH Study Center GmbH & Co. KG

Hamburg, 20146, Germany

Location

University of Naples Federico II

Bergamo, 24127, Italy

Location

UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1

Brescia, 25100, Italy

Location

Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele

Milan, 20127, Italy

Location

U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS

Roma, 00149, Italy

Location

U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

National Hospital Organization Nagoya Medical Center

Nagoya, 460-0001, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Tokyo Medical University Hospital

Tokyo, 1600023, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Tokyo, 1628655, Japan

Location

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, 4302, South Africa

Location

Helen Joseph Hospital

Johannesburg, 2092, South Africa

Location

Vx Pharma

Pretoria, 87, South Africa

Location

Perinatal HIV Research Unit (PHRU)

Soweto, 2013, South Africa

Location

Hospital Universitari Germans Trías i Pujol

Badalona, 08916, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 22060, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan, 33004, Taiwan

Location

Thai Red Cross AIDS Research Center

Bangkok, 10330, Thailand

Location

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, 11000, Thailand

Location

Related Publications (21)

  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 38085652BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 37451297BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 36082606BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 35544387BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 41459297BACKGROUND
  • 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.

    PMID: 39873394BACKGROUND
  • 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.

    PMID: 39912752BACKGROUND
  • 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.

    PMID: 39206943BACKGROUND

Related Links

MeSH Terms

Interventions

lenacapavir

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

November 4, 2019

Study Start

November 21, 2019

Primary Completion

October 5, 2020

Study Completion (Estimated)

January 1, 2027

Last Updated

March 13, 2026

Results First Posted

October 20, 2021

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations