Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2019 by United BioPharma

Sponsor
United BioPharma

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

Information provided by (Responsible Party)
United BioPharma
ClinicalTrials.gov Identifier
NCT03743376

First received: November 12, 2018
Last updated: July 8, 2019
Last Verified: July 2019
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV-1 Infection

Biological : UB-421(25 mg/kg) Q2W
Biological : UB-421(25 mg/kg) Q4W
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by United BioPharma:

Primary Outcome Measures

  • treatment related TEAEs [ Time Frame: 48Weeks ]
    the incidence of Grade 3 drug-related treatment-emergent adverse events
Secondary Outcome Measures:
  • the change of immune profiles [ Time Frame: 16Weeks ]
    Change in Treg percentage in the peripheral blood

Estimated Enrollment: 39
Anticipated Study Start Date: August 1, 2019
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
No Intervention: Standard ART
Subjects will receive standard ART for 48 weeks
Experimental: UB-421(25mg/kg) Q2W add-on treatment
UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
Biological: UB-421(25 mg/kg) Q2W

Monoclonal antibody by IV infusion plus standard ART

Experimental: UB-421(25mg/kg) Q4W add-on treatment
UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks
Biological: UB-421(25 mg/kg) Q4W

Monoclonal antibody by IV infusion plus standard ART

Eligibility

Eligibility

Ages Eligible for Study: 20 Years to 100 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03743376

Contacts

Contact:   Evelyn Lee +886-3-668-4800 ext 3201 evelyn.lee@unitedbiopharma.com
Contact:   Zhonghao Shi +886-3-668-4800 ext 3204 zhonghao.shi@unitedbiopharma.com

Locations

Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Evelyn Lee    evelyn.lee@unitedbiopharma.com
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan
Contact: Evelyn Lee    evelyn.lee@unitedbiopharma.com
Principal Investigator: Hung-Chin Tsai
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 201
Contact: Evelyn Lee    evelyn.lee@unitedbiopharma.com

Sponsors and Collaborators

United BioPharma
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Taoyuan General Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital.
More Information

More Information


Responsible Party: United BioPharma  
ClinicalTrials.gov Identifier: NCT03743376   History of Changes  
Other Study ID Numbers: UBP-A209-HIV  
Study First Received: November 12, 2018  
Last Updated: July 8, 2019  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

ClinicalTrials.gov processed this data on July 22, 2019
This information is provided by ClinicalTrials.gov.