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Monoclonal Antibodies
UB-421 for Multi-Drug Resistant HIV
Phase 2
Recruiting
Led By Mohammad A Rai, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 7) to day 21
Awards & highlights
Study Summary
This trial tests if a new drug (UB-421) can treat HIV in people who are resistant to anti-HIV drugs. Eligible participants aged 18+ will have physical exams & blood/urine tests and receive the drug once a week for 26 weeks.
Who is the study for?
Adults over 18 with HIV resistant to standard treatments, CD4+ T cell counts above 350 cells/mm3, and a life expectancy greater than 6 months. Participants must have documented resistance to drugs in at least three classes of antiretroviral medications but sensitivity to at least one FDA-approved drug. They should not be on certain other HIV treatments and must use effective contraception if of reproductive potential.Check my eligibility
What is being tested?
The trial is testing UB-421, an anti-CD4 antibody, combined with optimized background antiretroviral therapy (OBT) for people with multi-drug resistant HIV-1 infection. Over the course of 35 weeks, participants will receive weekly infusions of UB-421 and undergo regular health checks including blood tests and apheresis.See study design
What are the potential side effects?
While specific side effects are not listed here, similar therapies often cause immune reactions or infusion-related responses such as fever or chills. There may also be risks associated with frequent blood draws like bruising or infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment phase
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with =0.5 log10 reduction in HIV-1 plasma viremia
The number of grade 2 or higher adverse events (AEs)
Secondary outcome measures
CD8-Positive T-Lymphocytes
Measured levels of anti-UB-421 antibodies
Measured levels of serum UB-421 concentration
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
10 adults (>18 years of age) with human immunodeficiency virus (HIV) who demonstrate evidence of HIV-1 replication despite ongoing ART with documented genotypic and/or phenotypic resistance to multiple classes of HIV drugs (3 classes or more)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UB-421
2015
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,274 Previous Clinical Trials
5,484,335 Total Patients Enrolled
Mohammad A Rai, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on antiretroviral therapy for at least 6 months.I have not had radiation therapy in the last 4 weeks.I do not have any severe illness or condition that would make me unsuitable for the study.I have not had a severe AIDS-related illness in the last 3 months.I have not had HIV immunotherapy in the last 12 weeks.I have chronic hepatitis B or C.I have not had a fever or flu-like symptoms in the last 14 days.I have previously used UB-421.I am 18 years old or older.My virus responds to at least one approved antiviral drug.I have been on antiretroviral therapy for at least 6 months.I have been on a stable but unsuccessful HIV treatment for at least 8 weeks, or I stopped my unsuccessful HIV treatment within the last 8 weeks and am willing to stay off it until day 21 of the study. I haven't used fostemsavir unsuccessfully.I am currently undergoing chemotherapy or radiation for cancer.I have been on a stable but unsuccessful HIV treatment for at least 8 weeks.My HIV treatment has failed for drugs in three different classes.My HIV is treatable with at least one standard drug, but I'm not currently on enfuvirtide, ibalizumab, or maraviroc.I have a history of serious heart or brain blood vessel problems.I am using or agree to use effective birth control during and after the study.I am using two forms of birth control or practicing complete abstinence.I have not taken immunosuppressive drugs in the last 3 months.I am willing to follow the treatment plan without changes, except for managing side effects or if the treatment fails.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 1
HIV Patient Testimony for trial: Trial Name: NCT05582694 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to enroll in this research project?
"The clinical trial referenced is not recruiting patients at this time. This is according to the study's profile on clinicaltrials.gov, which also reveals that the last update was on November 17th, 2022. There are however, 1307 other studies currently looking for participants."
Answered by AI
At what level does 1 become dangerous for people?
"This Phase 2 trial has received a score of 2 because while there is some data supporting safety, there is no data yet available to support efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Pennsylvania
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
National Institutes of Health Clinical Center
Why did patients apply to this trial?
To help with the research.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
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