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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

U

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Withdrawn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)

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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