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
Information provided by (Responsible Party)
First received: July 31, 2019
Last updated: February 18, 2020
Last Verified: November 2019
History of Changes
This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.
Biological : UB-421
Other : Antiretroviral Therapy (ART)
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II, Open-label, Controlled, Proof-of-concept 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|
Further study details as provided by United BioPharma:
Primary Outcome Measures
treatment related TEAEs
[ Time Frame: 16 Weeks ]
the incidence of Grade 3 drug-related treatment-emergent adverse events
|Study Start Date:||April 2020|
|Estimated Study Completion Date:||March 2021|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Arm1 (Standard ART)
Antiretroviral Therapy (ART)
Arm 2 (ART plus UB-421)
ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks
Monoclonal antibody by IV infusion plus standard ART
Other: Antiretroviral Therapy (ART)
|Ages Eligible for Study:||20 Years to 100 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- HIV-1 seropositive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- have been receiving antiretroviral therapy (ART) for more than 2 years
- Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.
- History of anaphylaxis to monoclonal antibodies.
- Any vaccination within 8 weeks prior to the first dose of UB-421.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT04041362
Sponsors and CollaboratorsUnited BioPharma
|Responsible Party:||United BioPharma|
|ClinicalTrials.gov Identifier:||NCT04041362 History of Changes|
|Other Study ID Numbers:||UBP-A213-HIV|
|Study First Received:||July 31, 2019|
|Last Updated:||February 18, 2020|
|Individual Participant Data|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Keywords provided by United BioPharma:HIV
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.