The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

HIV-1 Infection Clinical Trial

Official title:

The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743376
• Other study ID #: UBP-A209-HIV
• Status: Completed
• Phase: Phase 2
• Start date: December 12, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: United BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluate the safety of UB-421 in combination with standard antiretroviral therapy (ART) and the efficacy of HIV reservoir reduction as compared with ART alone in ART stabilized HIV-1 patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 31, 2021
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

1. HIV-1 sero-positive

2. Male with body weight = 50 kg or female with body weight = 45 kg.

3. HIV-1 plasma RNA level below 50 RNA copies/mL .

Exclusion Criteria:

1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.

2. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.

3. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.

4. History of anaphylaxis to other mAbs.

5. Any vaccination within 8 weeks prior to the first dose of assigned drug.

6. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.

7. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Biological:
• UB-421(25 mg/kg) Q2W
Monoclonal antibody by IV infusion plus standard ART
• UB-421(25 mg/kg) Q4W
Monoclonal antibody by IV infusion plus standard ART

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (6)

Lead Sponsor	Collaborator
United BioPharma	Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital., National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Taoyuan General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment related TEAEs	the incidence of Grade 3 drug-related treatment-emergent adverse events	48Weeks
Secondary	the change of immune profiles	Change in Treg percentage in the peripheral blood	16Weeks