- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Teropavimab and Zinlirvimab Sensitivity in People Living With MDR HIV-1: PRESTIGIO Registry Data (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_896; P A significant number of the analyzed 4DR-PWH were found to have virus susceptible to TAB and ZAB. These data provide proof-of-concept that selected multidrug-resistant PWH may be candidates for future trials investigating bNAbs-containing regimens to achieve or maintain virologic suppression.
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Lenacapavir Plus bNAbs for People With HIV and Sensitivity to Either Teropavimab or Zinlirvimab () - Mar 5, 2024 - Abstract #CROI2024CROI_225; P1b The long-acting combination of LEN+TAB+ZAB was well tolerated, with a favorable safety profile. All participants in the higher ZAB dose group maintained VS for 6 months, which suggests that more inclusive sensitivity criteria may be appropriate for treatment studies of LEN+TAB+ZAB when higher bNAb levels are maintained.
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial completion, Combination therapy: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - Oct 27, 2023 P1b, N=32, Completed, HIV-1 suppression for at least 26 weeks is feasible with this regimen at either zinlirvimab dose in selected people with HIV-1. Active, not recruiting --> Completed
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment change, Combination therapy: A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - Jul 5, 2023 P2, N=75, Recruiting, N=30 --> 0 | Suspended --> Withdrawn N=125 --> 75
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial primary completion date, Combination therapy: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - Jun 15, 2023 P1b, N=32, Active, not recruiting, Trial primary completion date: Jun 2022 --> Dec 2023 Trial primary completion date: Jun 2022 --> Apr 2023
- |||||||||| Journal: Broadly neutralizing antibodies and long-acting antiretroviral drugs as treatments for HIV. (Pubmed Central) - Jun 7, 2023
In addition, the need to perform bNAb susceptibility testing to assure activity of the bNAb in order to protect against the risk of developing resistance to the LA ARV has slowed enrollment into trials and poses substantial logistical challenges to widespread adoption of these combinations should they prove safe and effective. Improvements in manufacture that reduce the cost of goods and advances in delivery systems are needed to ensure equitable access to these regimens.
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment open, Combination therapy: A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - May 31, 2023 P2, N=125, Recruiting, Improvements in manufacture that reduce the cost of goods and advances in delivery systems are needed to ensure equitable access to these regimens. Not yet recruiting --> Recruiting
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
New P2 trial, Combination therapy: A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - Feb 15, 2023 P2, N=125, Not yet recruiting,
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment open: 3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov) - Nov 3, 2022 P1, N=36, Recruiting, Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial completion date, Trial initiation date, Trial primary completion date: RHIVIERA-02: Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control (clinicaltrials.gov) - Oct 19, 2022 P2, N=60, Not yet recruiting, Not yet recruiting --> Recruiting Trial completion date: Feb 2028 --> Dec 2028 | Initiation date: Apr 2022 --> Dec 2022 | Trial primary completion date: Feb 2026 --> Dec 2026
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial completion date, Trial initiation date, Trial primary completion date: 3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov) - Sep 14, 2022 P1, N=36, Not yet recruiting, Trial completion date: Feb 2028 --> Dec 2028 | Initiation date: Apr 2022 --> Dec 2022 | Trial primary completion date: Feb 2026 --> Dec 2026 Trial completion date: Sep 2025 --> Dec 2025 | Initiation date: Aug 2022 --> Nov 2022 | Trial primary completion date: Sep 2024 --> Dec 2024
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment change, Combination therapy: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - Jun 27, 2022 P1b, N=41, Active, not recruiting, Trial completion date: Sep 2025 --> Dec 2025 | Initiation date: Aug 2022 --> Nov 2022 | Trial primary completion date: Sep 2024 --> Dec 2024 N=21 --> 41
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment change, Trial primary completion date, Combination therapy: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - May 5, 2022 P1b, N=21, Active, not recruiting, N=21 --> 41 N=50 --> 21 | Trial primary completion date: Oct 2022 --> Jun 2022
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial initiation date: 3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov) - Apr 20, 2022 P1, N=36, Not yet recruiting, N=50 --> 21 | Trial primary completion date: Oct 2022 --> Jun 2022 Initiation date: Mar 2022 --> Jun 2022
- |||||||||| GS5423 / Rockefeller University, Gilead, 10-1074-LS / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Clinical protocol, P2 data, Journal: The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol for a two-stage randomised phase II trial. (Pubmed Central) - Apr 13, 2022 This included the two-stage design, discussion on the criteria to restart ART, frequency of monitoring visits off ART, and reducing the risk of onward transmission to HIV-negative partners. It also included responding to the challenges of COVID-19.
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
New P1 trial: 3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov) - Feb 17, 2022 P1, N=36, Not yet recruiting,
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial completion: 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals (clinicaltrials.gov) - Feb 15, 2022 P1, N=6, Completed, Initiation date: Nov 2021 --> May 2022 Active, not recruiting --> Completed
- |||||||||| GS5423 / Rockefeller University, Gilead, 10-1074-LS / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
PHASE I STUDY OF LONG-ACTING 3BNC117 AND 10-1074 IN VIREMIC ADULTS LIVING WITH HIV ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_395; In this pilot study, the long-acting (LS) 3BNC117 and 10-1074 combination preserved antiviral activity and the potential to maintain long-term viral suppression in participants with sensitive viruses. Baseline antibody sensitivity of plasma viruses determined by the PhenoSense mAb Assay correlated with viremia decline and long-term suppression.
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment closed, Combination therapy: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - Jan 19, 2022 P1b, N=50, Active, not recruiting, Baseline antibody sensitivity of plasma viruses determined by the PhenoSense mAb Assay correlated with viremia decline and long-term suppression. Recruiting --> Active, not recruiting
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial completion date, Combination therapy: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - Oct 4, 2021 P1b, N=50, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Oct 2023 --> Jan 2024
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment closed, Enrollment change: 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals (clinicaltrials.gov) - Sep 23, 2021 P1, N=6, Active, not recruiting, Trial completion date: Oct 2023 --> Jan 2024 Recruiting --> Active, not recruiting | N=10 --> 6
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: First-in-human Study of 10-1074-LS Alone and in Combination With 3BNC117-LS (clinicaltrials.gov) - Aug 4, 2021 P1, N=77, Completed, Recruiting --> Active, not recruiting | N=10 --> 6 Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Feb 2021 | Trial primary completion date: Jun 2021 --> Feb 2021
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment open, Combination therapy: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - Apr 14, 2021 P1b, N=50, Recruiting, Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| Sunlenca (lenacapavir) / Gilead, teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
New P1 trial, Combination therapy: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection (clinicaltrials.gov) - Mar 22, 2021 P1b, N=50, Not yet recruiting,
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial completion date, Trial initiation date, Trial primary completion date: RIO: A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs). (clinicaltrials.gov) - Feb 22, 2021 P2, N=72, Not yet recruiting, Not yet recruiting --> Recruiting Trial completion date: Oct 2024 --> Mar 2025 | Initiation date: Jan 2021 --> Apr 2021 | Trial primary completion date: Nov 2021 --> Jun 2022
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment open: 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals (clinicaltrials.gov) - Aug 9, 2020 P1, N=10, Recruiting, Initiation date: May 2020 --> Jan 2021 Not yet recruiting --> Recruiting
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial initiation date: 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals (clinicaltrials.gov) - Apr 14, 2020 P1, N=10, Not yet recruiting, Not yet recruiting --> Recruiting Initiation date: Feb 2020 --> Jul 2020
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment closed, Combination therapy: First-in-human Study of 10-1074-LS Alone and in Combination With 3BNC117-LS (clinicaltrials.gov) - Apr 12, 2020 P1, N=75, Active, not recruiting, Initiation date: Feb 2020 --> Jul 2020 Recruiting --> Active, not recruiting
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
New P1 trial: 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals (clinicaltrials.gov) - Jan 30, 2020 P1, N=10, Not yet recruiting,
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: First-in-human Study of 10-1074-LS Alone and in Combination With 3BNC117-LS (clinicaltrials.gov) - Jun 27, 2019 P1, N=75, Recruiting, Recruiting --> Active, not recruiting N=57 --> 75 | Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021
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