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- | UB-421 IV / United BioPharma
Preclinical, Journal, PD(L)-1 Biomarker, IO biomarker: Ex (Pubmed Central) - Jun 16, 2024
Our data suggest that combination therapy with HIV-specific bNAbs and/or UB-421 in the presence of optimized background therapy could potentially provide sustained virologic suppression in PLWH with MDR HIV. However, this therapeutic strategy needs to be evaluated in human clinical trials.
- Development of Individualized Antibody Treatment Regimens for Patients With Multidrug-Resistant HIV (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_898;
The data from our study has direct clinical implications. Our data suggest that the therapeutic options for heavily treatment-experienced PLWH with MDR viruses could be potentially expanded to include HIV-specific bNAbs and UB-421, an avenue that has not been explored until now.
- | UB-421 IV / United BioPharma
Enrollment open, Combination therapy: A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection (clinicaltrials.gov) - Jun 9, 2023
P2, N=25, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Our data suggest that the therapeutic options for heavily treatment-experienced PLWH with MDR viruses could be potentially expanded to include HIV-specific bNAbs and UB-421, an avenue that has not been explored until now. Not yet recruiting --> Recruiting
- | UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Combination therapy: A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir (clinicaltrials.gov) - May 10, 2023
P2, N=20, Not yet recruiting, Sponsor: UBP Greater China (Shanghai) Co., Ltd
Not yet recruiting --> Recruiting Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
- || UB-421 IV / United BioPharma
Enrollment change, Trial withdrawal, Monotherapy: To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - Apr 25, 2023
P3, N=0, Withdrawn, Sponsor: United BioPharma
Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026 N=520 --> 0 | Recruiting --> Withdrawn
- | UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Combination therapy: UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection (clinicaltrials.gov) - Apr 24, 2023
P3, N=50, Not yet recruiting, Sponsor: United BioPharma
N=520 --> 0 | Recruiting --> Withdrawn Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
- UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Combination therapy: UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - Apr 24, 2023
P2, N=10, Not yet recruiting, Sponsor: United BioPharma
Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026 Trial completion date: May 2023 --> May 2024 | Trial primary completion date: Mar 2023 --> Mar 2024
- || UB-421 IV / United BioPharma
Trial completion, Trial completion date, Trial primary completion date: A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs (clinicaltrials.gov) - Feb 15, 2023
P2, N=11, Completed, Sponsor: United BioPharma
Trial completion date: May 2023 --> May 2024 | Trial primary completion date: Mar 2023 --> Mar 2024 Recruiting --> Completed | Trial completion date: Dec 2023 --> Feb 2023 | Trial primary completion date: Jun 2023 --> Feb 2023
- | UB-421 IV / United BioPharma
New P2 trial, Combination therapy: A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection (clinicaltrials.gov) - Oct 17, 2022
P2, N=25, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- | UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Combination therapy: A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir (clinicaltrials.gov) - Aug 31, 2022
P2, N=20, Not yet recruiting, Sponsor: UBP Greater China (Shanghai) Co., Ltd
Recruiting --> Completed | Trial completion date: Dec 2023 --> Feb 2023 | Trial primary completion date: Jun 2023 --> Feb 2023 Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
- | UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Combination therapy: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - May 18, 2022
P2, N=39, Not yet recruiting, Sponsor: UBP Greater China (Shanghai) Co., Ltd
Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025 Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2024
- UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Combination therapy: UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - May 13, 2022
P2, N=10, Not yet recruiting, Sponsor: United BioPharma
Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2024 Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
- |||| UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Monotherapy: To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - May 13, 2022
P3, N=520, Recruiting, Sponsor: United BioPharma
Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Mar 2022 --> Mar 2023 Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
- || UB-421 IV / United BioPharma
Trial completion, Combination therapy: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - May 13, 2022
P2, N=31, Completed, Sponsor: United BioPharma
Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025 Active, not recruiting --> Completed
- | UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Combination therapy: UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection (clinicaltrials.gov) - May 13, 2022
P3, N=50, Not yet recruiting, Sponsor: United BioPharma
Active, not recruiting --> Completed Trial completion date: Jun 2022 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2025
- |||||| UB-421 IV / United BioPharma
Enrollment open, Trial completion date, Trial primary completion date, Monotherapy: To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - Mar 29, 2022
P3, N=520, Recruiting, Sponsor: United BioPharma
Trial completion date: Jun 2022 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2025 Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- ||| P2 data, P3 data, Review, Journal: Emerging drugs for the treatment of HIV/AIDS: A Review of 2019/2020 phase II and III trials. (Pubmed Central) - Jan 27, 2022
UB-421 and VRC01 are monoclonal antibodies against HIV. This emerging technology has shown interesting results, but needs further studies.
- UB-421 IV / United BioPharma
Enrollment open, Trial primary completion date: A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs (clinicaltrials.gov) - Dec 21, 2021
P2, N=10, Recruiting, Sponsor: United BioPharma
This emerging technology has shown interesting results, but needs further studies. Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2022 --> Jun 2023
- UB-421 IV / United BioPharma
New P2 trial: A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs (clinicaltrials.gov) - Sep 26, 2021
P2, N=10, Not yet recruiting, Sponsor: United BioPharma
- || UB-421 IV / United BioPharma
New P2 trial, Combination therapy: A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir (clinicaltrials.gov) - Aug 1, 2021
P2, N=20, Not yet recruiting, Sponsor: UBP Greater China (Shanghai) Co., Ltd
- UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Combination therapy: UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - May 10, 2021
P2, N=10, Not yet recruiting, Sponsor: United BioPharma
Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2022 --> Jun 2023 Trial completion date: Nov 2020 --> May 2022 | Trial primary completion date: Sep 2020 --> Mar 2022
- || UB-421 IV / United BioPharma
Trial initiation date, Combination therapy: UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection (clinicaltrials.gov) - Apr 28, 2021
P3, N=50, Not yet recruiting, Sponsor: United BioPharma
Trial completion date: Nov 2020 --> May 2022 | Trial primary completion date: Sep 2020 --> Mar 2022 Initiation date: Jun 2020 --> Dec 2021
- | UB-421 IV / United BioPharma
Trial initiation date, Combination therapy: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - Apr 28, 2021
P2, N=39, Not yet recruiting, Sponsor: UBP Greater China (Shanghai) Co., Ltd
Initiation date: Jun 2020 --> Dec 2021 Initiation date: Jun 2020 --> Dec 2021
- | UB-421 IV / United BioPharma
Enrollment closed, Trial completion date, Combination therapy: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - Feb 5, 2021
P2, N=31, Active, not recruiting, Sponsor: United BioPharma
Initiation date: Jun 2020 --> Dec 2021 Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Dec 2021
- |||| UB-421 IV / United BioPharma
New P3 trial, Combination therapy: UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection (clinicaltrials.gov) - May 27, 2020
P3, N=50, Not yet recruiting, Sponsor: United BioPharma
- | UB-421 IV / United BioPharma
New P2 trial, Combination therapy: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - May 26, 2020
P2, N=39, Not yet recruiting, Sponsor: UBP Greater China (Shanghai) Co., Ltd
- UB-421 IV / United BioPharma
Phase classification, Combination therapy: UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - May 22, 2020
P2, N=10, Not yet recruiting, Sponsor: United BioPharma
Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Dec 2021 Phase classification: P2/3 --> P2
- UB-421 IV / United BioPharma
Trial primary completion date, Combination therapy: UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - Mar 25, 2020
P2/3, N=10, Not yet recruiting, Sponsor: United BioPharma
Phase classification: P2/3 --> P2 Trial primary completion date: May 2020 --> Sep 2020
- |||| UB-421 IV / United BioPharma
Trial completion date, Trial primary completion date, Monotherapy: To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - Mar 25, 2020
P3, N=520, Not yet recruiting, Sponsor: United BioPharma
Trial primary completion date: May 2020 --> Sep 2020 Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Dec 2022
- | UB-421 IV / United BioPharma
Enrollment change, Trial withdrawal, Combination therapy: the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients (clinicaltrials.gov) - Feb 23, 2020
P2, N=0, Withdrawn, Sponsor: United BioPharma
Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Dec 2022 N=14 --> 0 | Not yet recruiting --> Withdrawn
- | UB-421 IV / United BioPharma
New P2 trial, Combination therapy: the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients (clinicaltrials.gov) - Jul 31, 2019
P2, N=14, Not yet recruiting, Sponsor: United BioPharma
- || UB-421 IV / United BioPharma
Enrollment open, Combination therapy: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - Jun 23, 2019
P2, N=39, Recruiting, Sponsor: United BioPharma
N=14 --> 0 | Not yet recruiting --> Withdrawn Not yet recruiting --> Recruiting
- ||||| UB-421 IV / United BioPharma
Enrollment change, Combination therapy: UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - May 31, 2019
P2/3, N=10, Not yet recruiting, Sponsor: United BioPharma
Not yet recruiting --> Recruiting N=30 --> 10
- ||||| UB-421 IV / United BioPharma
Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date, Monotherapy: To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - Apr 3, 2019
P3, N=520, Not yet recruiting, Sponsor: United BioPharma
N=30 --> 10 N=375 --> 520 | Trial completion date: Dec 2021 --> Jun 2022 | Initiation date: Jul 2019 --> Jan 2020 | Trial primary completion date: Dec 2021 --> Jun 2022
- | UB-421 IV / United BioPharma
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - Apr 3, 2019
P2, N=39, Not yet recruiting, Sponsor: United BioPharma
N=375 --> 520 | Trial completion date: Dec 2021 --> Jun 2022 | Initiation date: Jul 2019 --> Jan 2020 | Trial primary completion date: Dec 2021 --> Jun 2022 Trial completion date: Jul 2020 --> Dec 2020 | Initiation date: Mar 2019 --> Aug 2019 | Trial primary completion date: Jul 2020 --> Dec 2020
- ||| UB-421 IV / United BioPharma
Enrollment change, Combination therapy: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - Dec 27, 2018
P2, N=39, Not yet recruiting, Sponsor: United BioPharma
Trial completion date: Jul 2020 --> Dec 2020 | Initiation date: Mar 2019 --> Aug 2019 | Trial primary completion date: Jul 2020 --> Dec 2020 N=30 --> 39
- | UB-421 IV / United BioPharma
New P2 trial, Combination therapy: The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - Nov 16, 2018
P2, N=30, Not yet recruiting, Sponsor: United BioPharma
- | UB-421 IV / United BioPharma
Trial initiation date, Combination therapy: UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - Oct 15, 2018
P2/3, N=30, Not yet recruiting, Sponsor: United BioPharma
N=30 --> 39 Initiation date: Sep 2018 --> Sep 2019
- | UB-421 IV / United BioPharma
Trial initiation date, Monotherapy: To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - Oct 15, 2018
P3, N=375, Not yet recruiting, Sponsor: United BioPharma
Initiation date: Sep 2018 --> Sep 2019 Initiation date: Sep 2018 --> Jul 2019
- ||||| UB-421 IV / United BioPharma
Trial initiation date, Monotherapy: To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - Oct 26, 2017
P3, N=375, Not yet recruiting, Sponsor: United BioPharma
Initiation date: Sep 2018 --> Jul 2019 Initiation date: Jan 2018 --> Sep 2018
- | UB-421 IV / United BioPharma
Trial initiation date, Trial primary completion date, Combination therapy: UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - Oct 26, 2017
P2/3, N=30, Not yet recruiting, Sponsor: United BioPharma
Initiation date: Jan 2018 --> Sep 2018 Initiation date: Sep 2017 --> Sep 2018 | Trial primary completion date: May 2019 --> May 2020
- ||| UB-421 IV / United BioPharma
New P2/3 trial, Combination therapy: UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - May 23, 2017
P2/3, N=30, Not yet recruiting, Sponsor: United BioPharma
- |||||||||| UB-421 IV / United BioPharma
New P3 trial, Monotherapy: To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - May 10, 2017
P3, N=375, Not yet recruiting, Sponsor: United BioPharma
- | UB-421 IV / United BioPharma
Trial completion, Trial primary completion date, Monotherapy: To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults (clinicaltrials.gov) - Aug 3, 2016
P2, N=28, Completed, Sponsor: United BioPharma
Initiation date: Sep 2017 --> Sep 2018 | Trial primary completion date: May 2019 --> May 2020 Recruiting --> Completed | Trial primary completion date: Dec 2016 --> Jul 2016
- UB-421 IV / United BioPharma
Enrollment open, Monotherapy: To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults (clinicaltrials.gov) - Jun 20, 2015
P2, N=28, Recruiting, Sponsor: United BioPharma
Recruiting --> Completed | Trial primary completion date: Dec 2016 --> Jul 2016 Not yet recruiting --> Recruiting
- UB-421 IV / United BioPharma
New P2 trial, Monotherapy: To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults (clinicaltrials.gov) - Feb 23, 2015
P2, N=28, Not yet recruiting, Sponsor: United BioPharma
- | UB-421 IV / United BioPharma
Trial completion, Enrollment change, Trial primary completion date: Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults (clinicaltrials.gov) - Aug 21, 2014
P2a, N=29, Completed, Sponsor: United Biomedical
Not yet recruiting --> Recruiting Recruiting --> Completed | N=20 --> 29 | Trial primary completion date: Dec 2012 --> Mar 2014
- | UB-421 IV / United BioPharma
Enrollment open: Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults (clinicaltrials.gov) - Sep 19, 2012
P2a, N=20, Recruiting, Sponsor: United Biomedical
Recruiting --> Completed | N=20 --> 29 | Trial primary completion date: Dec 2012 --> Mar 2014 Not yet recruiting --> Recruiting
- | UB-421 IV / United BioPharma
New P2a trial: Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults (clinicaltrials.gov) - Aug 15, 2012
P2a, N=20, Recruiting, Sponsor: United Biomedical