Recruiting soon

UB-421 and Optimized Background Regimen for Multi-drug Resistant HIV-1 Infection

What is being tested

UB-421

+ Antiretroviral (ARV)

BiologicalOther

Who is being recruted

Over 20 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: December 2023

See protocol details

Summary

Principal SponsorUnited BioPharma

Study ContactLinda ShihMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2023

Actual date on which the first participant was enrolled.

This is a phase 3 study looking into the effectiveness of a drug called UB-421 in combination with other HIV treatments, for patients with multi-drug resistant HIV-1 infection. The goal is to find out if UB-421 can help reduce the amount of HIV virus in the blood when used with other medications. This is important because it could potentially offer a new treatment option for those who aren't responding well to current treatments. In this trial, participants are randomly assigned to receive either UB-421 or a placebo, along with their current HIV treatment regimen. The main outcome being measured is the change in the amount of HIV-1 RNA viral load, which is a way to assess how well the treatment is controlling the virus. The study compares this change between the group receiving UB-421 and the group receiving the placebo.

Official TitleA Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

NCT04406727

Principal SponsorUnited BioPharma

Study ContactLinda ShihMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

HIV-1 seropositive

Have a history of at least 6 months on antiretroviral treatment

Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening

4 exclusion criteria prevent from participating

Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN)

Females who are pregnant

Any vaccination within 2 weeks prior to the Screening

Any prior exposure to UB-421

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).

Group II

Active Comparator

2-arm Comparison Phase: Placebo in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers