the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

United BioPharma

Status and phase: Withdrawn; Phase 2

Conditions: HIV-1 Infection

Treatments: Other: Antiretroviral Therapy (ART); Biological: UB-421

Study type: Interventional

Funder types: Industry

Identifiers

NCT04041362

UBP-A213-HIV

Details and patient eligibility

About

This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HIV-1 seropositive
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
3. have been receiving antiretroviral therapy (ART) for more than 2 years

Exclusion criteria

1. Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.
2. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.
3. History of anaphylaxis to monoclonal antibodies.
4. Any vaccination within 8 weeks prior to the first dose of UB-421.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm1 (Standard ART)

Active Comparator group

Description:

Standard ART

Treatment:

Other: Antiretroviral Therapy (ART)

Arm 2 (ART plus UB-421)

Experimental group

Description:

ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks

Treatment:

Biological: UB-421

Other: Antiretroviral Therapy (ART)