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UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients

NCT03164447 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-04-24

No results posted yet for this study

Summary

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.

Conditions

  • HIV-1 Infection

Interventions

BIOLOGICAL

UB-421

Monoclonal antibody by IV infusion

DRUG

Optimized background therapy (OBT)

The prescribed OBT must contain at least one agent to which the participant's virus is known to be fully sensitive.

Sponsors & Collaborators

  • United BioPharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-03-31
Completion
2024-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03164447 on ClinicalTrials.gov