A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs
NCT05056974 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2023-02-15
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.
Conditions
- HIV-1 Infection
Interventions
- BIOLOGICAL
-
UB-421
10 mg/kg, weekly UB-421 during the 8-week
- DRUG
-
chidamide
10 mg/dose, twice a week for 8 weeks
Sponsors & Collaborators
-
United BioPharma
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-02
- Primary Completion
- 2023-02-01
- Completion
- 2023-02-01
Countries
- Taiwan
More Related Trials
-
Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults
NCT02178800 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults
NCT01668043 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection
NCT05582694 ·Status: WITHDRAWN ·Phase: PHASE2
-
Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
NCT00050284 ·Status: COMPLETED
-
Safety and Immune Response of BMS-936559 in HIV-Infected People Taking Combination Antiretroviral Therapy
NCT02028403 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
NCT00002449 ·Status: UNKNOWN ·Phase: PHASE1
-
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
NCT04406727 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Safety Study of IL-7 in HIV-infected Patients (Inspire)
NCT00477321 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection
NCT00059462 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ART
NCT05144386 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS
NCT06902038 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells
NCT03856996 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Anti-HIV Monoclonal Antibody KD-247
NCT00917813 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy and Safety Study of Autologous Cluster of Differentiation 34 (CD34+) Hematopoietic Progenitor Cells Transduced With Placebo or an Anti- Human Immunodeficiency Virus Type 1 (HIV-1) Ribozyme (OZ1) in Participants With HIV-1 Infection
NCT00074997 ·Status: COMPLETED ·Phase: PHASE2
-
An Antiretroviral Treatment Interruption (ATI) Study to Evaluate the Impact of Genetically Modified Autologous Cells (AGT103-T) to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy
NCT05540964 ·Status: UNKNOWN
-
Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy
NCT06680479 ·Status: SUSPENDED ·Phase: PHASE1
-
Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers
NCT01292174 ·Status: COMPLETED ·Phase: PHASE1
-
Interluekin-7 to Treat HIV-Infected People Receiving Antiretroviral Treatment
NCT00105417 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3
NCT00000755 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Safety and Immunogenicity Vaccine Trial Against HIV/AIDS
NCT00505401 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons
NCT01218113 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults
NCT02960581 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
NCT00002004 ·Status: COMPLETED ·Phase: PHASE1
-
Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals
NCT03225118 ·Status: COMPLETED
-
Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV
NCT05330143 ·Status: COMPLETED ·Phase: PHASE2