A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs

HIV-1 Infection Clinical Trial

Official title:

A Phase II Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs Among ART Stabilized HIV-1 Patients Who Undergo ART Interruption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056974
• Other study ID #: UBP-A232-HIV
• Status: Completed
• Phase: Phase 2
• Start date: December 2, 2021
• Est. completion date: February 1, 2023

Study information

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

Clinical Trial Summary

This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART interruption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history

2. Male with body weight = 50 kg or female with body weight = 45 kg, aged 20 years or older.

3. No breastfeeding or pregnancy for women.

4. Have been receiving ART for more than 3 years by screening visit 1 (SV1).

5. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception

6. Subjects must sign the informed consent before undergoing any study procedures.

Exclusion Criteria:

1. Subjects with active systemic infections, except for HIV-1

2. Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.

3. Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis

4. Any alcohol or illicit drug use

5. Receipt of any other investigational study agent(s) within 90 days before SV2.

6. Currently on the treatment for diabetes.

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Biological:
• UB-421
10 mg/kg, weekly UB-421 during the 8-week

Drug:
• chidamide
10 mg/dose, twice a week for 8 weeks

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
United BioPharma

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV cell-associated RNA levels	The change in HIV-1 Total DNA from baseline after study drug administration.	Post-treatment weeks up to 48 weeks
Secondary	HIV-1 Total DNA levels	The changes in HIV-1 Total DNA levels during the study	Post-treatment weeks up to 48 weeks