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

UBP-A232-HIV

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.

2021-12-02

2023-02-01

2023-02-01

Completed

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2023-02-15