- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03164447
UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients
April 21, 2023 updated by: United BioPharma
A Multicenter, Single-Arm, 24-Week Study of UB-421 in Combination With Optimized Background Therapy (OBT) Regimen in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
This is a Phase 2, multi-center study, designed to evaluate the efficacy, safety, and tolerability of UB-421 in conjunction with a failing existing ART regimen for 1 week and optimized background therapy (OBT) for 24 weeks, respectively.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhonghao Shi
- Phone Number: 3641 +886-3-668-4800
- Email: Zhonghao.Shi@unitedbiopharma.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Males and females, age ≥18 years;
- HIV-1 seropositive, with documented HIV-1 infection by official, signed, written history (eg. Laboratory report);
- Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening and are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase;
- Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA >200 copies/ml) within the last 3 months prior to the Screening Visit;
- Highly treatment-experienced HIV-infected patients with documented genotypic and/or phenotypic resistance to at least one ARV drug within three or more drug classes of antiretroviral medications and have difficulty in constructing a viable suppressive regimen.
- Have full viral sensitivity/susceptibility to at least one approved antiretroviral agent, other than UB-421, as determined by genotypic and/or phenotypic ARV drug resistance tests at screening, and such agent can be used as a component of OBT;
- Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure;
- Have a life expectancy that is > 9 months;
Laboratory values at Screening of:
- Absolute neutrophil count (ANC) ≥ 750/mm3;
- Hemoglobin (Hb) ≥ 10.5 gm/dL (male) or ≥ 9.5 gm/dL (female);
- Platelets ≥ 75,000 /mm3;
- Serum alanine transaminase (SGPT/ALT) < 2.5 x upper limit of normal (ULN);
- Serum aspartate transaminase (SGOT/AST) < 2.5 x ULN;
- Bilirubin (total) < 2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease; and
- Creatinine ≤ 1.5 x ULN
- Clinically normal resting 12-lead electrocardiogram (ECG) at the Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
- 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,injectables, combination 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 the Screening Visit and negative urine pregnancy test prior to receiving the first dose of study drug; and
- Willing and able to participate in all aspects of the study, including use of IV medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
Exclusion Criteria:
- Any currently active AIDS-defining illness per Category C conditions according to the Center for Disease Control (CDC) Classification System for HIV Infection, with the following exceptions: local cutaneous Kaposi's sarcoma, wasting syndrome due to HIV or any other AIDS-defining illness for which no therapeutic treatment is required OR the required treatment is not included in the list of prohibited medications;
- Subjects with baseline liver disease including active Hepatitis B or C infection or any other active infection secondary to HIV requiring acute therapy;
- Subjects with baseline CD4 counts < 350 cells/mm^3.
- Any ≥ Grade 3 laboratory abnormality according to the division of AIDS grading scale;
- Unexplained fever or clinically significant illness within 2 weeks prior to the first dose of study drug;
- Any vaccination within 2 weeks prior to the first dose of study drug;
- Any immunomodulating therapy (excluding pre-medication steroid) or systemic chemotherapy within 4 weeks prior to the Screening Visit;
- Any radiation therapy within 4 weeks prior to the Screening Visit;
- Any previous exposure to monoclonal antibody for the treatment of HIV within 12 weeks prior to the Screening Visit (excluding ibalizumab);
- Participation in an experimental drug trial(s) within 4 weeks prior to the Screening Visit;
- Any prior exposure to UB-421;
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study; and
- Any significant diseases (other than HIV-1 infection) or clinically significant findings that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multi-Drug Resistant
|
Monoclonal antibody by IV infusion
The prescribed OBT must contain at least one agent to which the participant's virus is known to be fully sensitive.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effectiveness by Viral Load Log10 Change from Baseline
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with treatment-related adverse events
Time Frame: 35 weeks
|
35 weeks
|
Peak concentration of UB-421
Time Frame: 35 weeks
|
35 weeks
|
Trough concentration of UB-421
Time Frame: 35 weeks
|
35 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2023
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
May 21, 2017
First Submitted That Met QC Criteria
May 21, 2017
First Posted (Actual)
May 23, 2017
Study Record Updates
Last Update Posted (Actual)
April 24, 2023
Last Update Submitted That Met QC Criteria
April 21, 2023
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- HIV Infections
- Infections
- Communicable Diseases
- Anti-Infective Agents
- Antiviral Agents
- Anti-Retroviral Agents
- UB-421
Other Study ID Numbers
- UBP-A205-HIV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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