To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults
NCT ID: NCT02369146
Last Updated: 2017-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2015-06-30
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
cohort 1
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly
UB-421
The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).
cohort 2
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly
UB-421
The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
UB-421
The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged 20 years or older
* Have received HAART treatment
* CD4+ T cell count ≧ 350 cells/mm3
* HIV-1 plasma RNA level remains below the limit of
* Were not breastfeeding for women
* Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
* Subjects agree on using birth control barrier (female or male condom) during the entire study period
* Subjects sign the informed consent before undergoing any study procedures
Exclusion Criteria
* Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
* Any documented CD4+ T cell count \< 200 cells/mm3 within the past 12 weeks before screening visit
* Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
* Any vaccination within 8 weeks prior to the first dose of study drug
* Any immunomodulating therapy (including interferon and steroid) or systemic chemotherapy within 12 weeks prior to the first dose of study drug
* Any illicit intravenous drugs within 12 weeks prior to the first dose of study drug
* Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
* More than one change of HAART regimen because of virologic failure
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Kaohsiung Veterans General Hospital.
OTHER
Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
United BioPharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wing Wai Wong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Taiwan, Taipei Veterans General Hospital
Yen Hsu Chen, M.D. PhD.
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Medical University Chung-Ho Memorial Hospital
Hung Chin Tsai, M.D. PhD.
Role: PRINCIPAL_INVESTIGATOR
Taiwan, Kaohsiung Veterans General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wang CY, Wong WW, Tsai HC, Chen YH, Kuo BS, Lynn S, Blazkova J, Clarridge KE, Su HW, Lin CY, Tseng FC, Lai A, Yang FH, Lin CH, Tseng W, Lin HY, Finstad CL, Wong-Staal F, Hanson CV, Chun TW, Liao MJ. Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption. N Engl J Med. 2019 Apr 18;380(16):1535-1545. doi: 10.1056/NEJMoa1802264.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UBP-A202-HIV
Identifier Type: -
Identifier Source: org_study_id