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

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ClinicalTrials.gov Identifier: NCT03743376
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborators:
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

Brief Summary:
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 or disease Intervention/treatment Phase
HIV-1 Infection Biological: UB-421(25 mg/kg) Q2W Biological: UB-421(25 mg/kg) Q4W Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. treatment related TEAEs [ Time Frame: 48Weeks ]
    the incidence of Grade 3 drug-related treatment-emergent adverse events


Secondary Outcome Measures :
  1. the change of immune profiles [ Time Frame: 16Weeks ]
    Change in Treg percentage in the peripheral blood



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743376


Contacts
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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
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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.

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Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT03743376     History of Changes
Other Study ID Numbers: UBP-A209-HIV
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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

Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs