UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

April 21, 2023 updated by: United BioPharma

A 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

The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

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

Study Contact Backup

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. HIV-1 seropositive
  2. Have a history of at least 6 months on antiretroviral treatment
  3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening

Exclusion Criteria:

  1. Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN)
  2. Females who are pregnant
  3. Any vaccination within 2 weeks prior to the Screening
  4. Any prior exposure to UB-421

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UB-421

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).

UB-421 in combination with their ARV
Antiretroviral (ARV)
Active Comparator: Placebo

2-arm Comparison Phase: Placebo in combination with ARV

Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).

Antiretroviral (ARV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HIV-1 RNA viral load between 2 arms
Time Frame: 14 Days
14 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

June 30, 2026

Study Completion (Anticipated)

June 30, 2026

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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