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

HIV-1 Infection Clinical Trial

Official title:

A Phase II, Open-label, Controlled, Proof-of-concept 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04041362
• Other study ID #: UBP-A213-HIV
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2020
• Est. completion date: March 2021

Study information

• Verified date: November 2019
• Source: United BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Biological:
• UB-421
Monoclonal antibody by IV infusion plus standard ART

Other:
• Antiretroviral Therapy (ART)
Standard ART

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United BioPharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment related TEAEs	the incidence of Grade 3 drug-related treatment-emergent adverse events	16 Weeks