Clinical Trials List
2019-01-01 - 2023-12-31
Phase III
Not yet recruiting10
Recruiting1
ICD-10B20
Human immunodeficiency virus [HIV] disease
A phase III, randomized, open-label, controlled trial to investigate the efficacy and safety of UB-421 monotherapy as substitution for stable antiretroviral therapy in HIV-1 infected adults
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Trial Applicant
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Sponsor
United BioPharma
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Su-Jung Chen Division of Infectious Disease
- 顧文瑋 Division of Infectious Disease
- 陳昕白 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 黃文琦 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 林德宇 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Tun-Chieh Chen Division of Infectious Disease
- Chun-Yuan Lee Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
- 張雅婷 Division of Infectious Disease
- Po-Liang Lu Division of Infectious Disease
- Shang-Yi Lin Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- CHIEN-YU CHENG Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ho Mao-Wang Division of Infectious Disease
- 周家卉 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chi-Hung Lee Division of Infectious Disease
- Mei-Hui Lee Division of Infectious Disease
- 李繼弘醫師 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Fu-Lun Chen Division of Infectious Disease
- Tsong-Yih Ou Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
None
Co-Principal Investigator
- Nan-Yao Lee Division of Infectious Disease
- Po-Lin Chen Division of Infectious Disease
- 蔡進相 Division of Infectious Disease
- 薛伶珊 Division of Infectious Disease
- 李佳雯 Division of Infectious Disease
- 李明吉 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1. The proportion of subjects with plasma HIV-1 RNA < 50 copies/mL by FDA snapshot analysis at
week 24 (a week 22-26 window was used to determine the 24-week outcome) in the Intention-toTreat (ITT) population
Secondary endpoints:
1. The proportion of subjects with plasma HIV-1 RNA < 50 copies/mL by FDA snapshot analysis at
week 48 (a week 45-51 window was used to determine the 48-week outcome) in the ITT and PerProtocol (PP) population.
2. Time to virologic failure during the treatment period in the ITT and PP populations: from the baseline
(V1) until virologic failure, discontinuation, withdrawal, censoring, or the end of treatment.
Virologic failure (VF) is defined as two consecutive plasma HIV-1 RNA viral load measurements ≧
400 copies/mL with 4-week apart or one plasma HIV-1 RNA viral load measurement ≧ 1000
copies/mL.
3. The cumulative proportions of subjects who discontinue baseline combination antiretroviral therapy
(cART) regimen (Cohort 1) or UB-421 monotherapy (Cohort 2), and change to other combination(s)
of ART due to VF at each visit in the ITT and PP populations.
4. Safety and tolerability of UB-421 monotherapy and cART control arm as measured by the following
parameters in the ITT population.
– All treatment-emergent AEs (TEAEs), serious AEs and AEs leading to permanent treatment
discontinuation of UB-421 (tolerability) during the treatment period
– Frequency of treatment-emergent adverse events (TEAEs) of Grade 3 or above
– Changes in CD4+ and CD8+ T cell counts from the baseline
– Clinical significant changes in physical examinations, vital signs, ECG and clinical laboratory
parameters (hematology or clinical chemistry)
– Changes in blood test parameters related to the metabolic syndrome (e.g. LDL, HDL, TG,
Cholesterol, HbA1c, fasting glucose) as compared to baseline (V1) during study period. Details
will be given in the Statistical Analysis Plan (SAP).
– Serum levels of anti-UB-421 antibody in the immunogenicity population of Cohort 2
5. Factors related to the virologic failure will be explored between Cohort 2 (UB-421 treatment) and
Cohort 1 (the control drugs) during the treatment period in both the ITT and PP populations. Factors
considered will include but not limit to the types of baseline cART, i.e. P.I.-, NNRTI-, or INSTI- based
regimen, times and reasons of cART changed previously, baseline CD4+ and CD8+ T cell counts,
demographics, treatment adherence and HIV-1 factors (drug-resistance mutations, sub-genotypes,
viral blips). Similar analyses will be performed among UB-421-adhering sub-group by stratifying the
anti-UB-421 antibody status and other factors.
6. Pharmacokinetic parameters of UB-421 in the pharmacokinetic population of Cohort 2
7. Descriptive analysis of viral blips during the treatment and follow-up periods in both the ITT and PP
populations; viral blips are defined as 1) non-consecutive viral load increases ≧400 RNA copies/mL
but < 1000 RNA copies/mL other than the defined VF events, or 2) viral loads between 50 and 400
copies/mL.
Inclution Criteria
2.Male or female; aged 20 years or older
3.Subjects eligible for two or more potential alternative antiretroviral regimen options
4.Have received cART, defined as at least (≧) 2 nucleoside/ nucleotide reverse transcriptase inhibitors (NRTI) plus one non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI, either boosted or un-boosted), integrase strand transfer inhibitor (INSTI) or entry inhibitor (EI) for more than 1 year
5.With the most recent two consecutive measurements of CD4+ T cell count ≧ 350 cells/mm3 prior to screening visit
6.With a CD4+ T cell count ≧ 350 cells/mm3 obtained at screening visit
7.HIV-1 plasma RNA level remains below 50 RNA copies/mL for at least (≧) 12 months prior to screening visit, with at least 2 viral load measurements within 12 months. Viral load should also be below 50 RNA copies/mL within 4 weeks prior to or at screening visit. Single episode of detectable HIV-1 plasma RNA < 1000 RNA copies/ml measured 3 months before screening visit will not exclude subject participation if ≧ 2 other viral load measurements are below 50 RNA copies/mL in the last 12 months.
8.No breastfeeding for women
9.Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception [e.g. barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel), hormonal contraceptives (implants, injectable, combinational oral contraceptives, transdermal patches, or contraceptive rings), and intrauterine devices] during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at screening visit.
10.Subjects sign the informed consent before undergoing any study procedures
Exclusion Criteria
2.Any acquired AIDS-defining illness such as non-Hodgkin’s lymphoma or Kaposi’s sarcoma according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV-1 Infection within the past 12 months before screening visit
3.Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks before screening visit
4.Any previous exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug
5.Previously enrolled in any UB-421 trial (I, IIa or II)
6.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
7.Current active hepatitis B carriers, i.e. HBsAg positive
8.Current active hepatitis C carriers, i.e. HCV antibody and RNA double positive
9.Serum GPT/ALT value is 5 times greater than the upper limit of normal (>5xULN) at screening
10.Serum creatinine value is 1.8 times greater than the upper limit of normal (>1.8xULN) at screening
11.Anaphylaxis to monoclonal antibody drugs
12.Any vaccination within 8 weeks prior to the first dose of assigned drug
13.Immunomodulators, including interleukins, interferon, cyclosporine, systemic corticosteroid, HIV vaccine or systemic chemotherapy within 180 days prior to the first dose of assigned drug
14.Life expectancy less than 12 months
15.Any alcohol or illicit drug used, according to the investigator’s opinion, will interfere with the subject’s ability to comply with the dosing, visit schedules and protocol evaluations
16.More than one change of cART regimen because of the inability to achieve or maintain suppression of viral replication to an HIV-1 RNA level < 200 copies/mL within the past 12 months before screening visit.
17.Receipt of other investigational study agent within 90 days before screening visit
The Estimated Number of Participants
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Taiwan
174 participants
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Global
520 participants
