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

Phase 2

Completed

• Conditions: HIV-1 Infection
• Interventions: Biological: UB-421; Drug: chidamide

• Registration Number: NCT05056974
• Lead Sponsor: United BioPharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-09-27
• Study Start: 2021-12-02
• Status Verified: 2022-08
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UB-421 + chidamide	UB-421	UB-421 + chidamide combination therapy
UB-421 + chidamide	chidamide	UB-421 + chidamide combination therapy

Primary Outcome Measures

Name	Time	Method
HIV cell-associated RNA levels	Post-treatment weeks up to 48 weeks	The change in HIV-1 Total DNA from baseline after study drug administration.

Secondary Outcome Measures

Name	Time	Method
HIV-1 Total DNA levels	Post-treatment weeks up to 48 weeks	The changes in HIV-1 Total DNA levels during the study

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung City, Taiwan, Taiwan