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To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02369146
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : October 31, 2017
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Information provided by (Responsible Party):
United BioPharma

Study Description
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Brief Summary:
The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: UB-421 Phase 2

Detailed Description:
This is an open-label, Phase II study to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. In this study, approximately 29 subjects will be enrolled to receive one of the two UB-421 regimens as the monotherapy in replacement of HARRT treatment. Subjects assigned to Cohort 1 will receive UB-421 infusion at 10 mg/kg weekly for 8 weeks; subjects assigned to Cohort 2 will receive UB-421 infusion at 25 mg/kg bi-weekly for 16 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Multiple-dose Trial to Investigate the Safety and Efficacy of UB-421 Monotherapy in Substitution for Stable Antiretroviral Therapy in HIV Infected Adults
Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: cohort 1
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly
 Drug: UB-421
The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).
Other Name: dB4C7 mAb
Experimental: cohort 2
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly
 Drug: UB-421
The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).
Other Name: dB4C7 mAb


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 17 weeks for cohort 1, 25 weeks for cohort 2 ]

Secondary Outcome Measures :
  1. Peak concentration of UB-421 [ Time Frame: 8 weeks for cohort 1, 15 weeks for cohort 2 ]
  2. Trough concentration of UB-421 [ Time Frame: 8 weeks for cohort 1, 15 weeks for cohort 2 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 sero-positive
  • Aged 20 years or older
  • Have received HAART treatment
  • CD4+ T cell count ≧ 350 cells/mm3
  • HIV-1 plasma RNA level remains below the limit of
  • Were not breastfeeding for women
  • Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
  • Subjects agree on using birth control barrier (female or male condom) during the entire study period
  • Subjects sign the informed consent before undergoing any study procedures

Exclusion Criteria:

  • Any active infection except for HIV, and required immediate therapy
  • Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
  • Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks before screening visit
  • Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
  • Any vaccination within 8 weeks prior to the first dose of study drug
  • Any immunomodulating therapy (including interferon and steroid) or systemic chemotherapy within 12 weeks prior to the first dose of study drug
  • Any illicit intravenous drugs within 12 weeks prior to the first dose of study drug
  • Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
  • More than one change of HAART regimen because of virologic failure
Contacts and Locations
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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): NCT02369146


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
United BioPharma
Taipei Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Wing Wai Wong, M.D. Taiwan, Taipei Veterans General Hospital
Principal Investigator: Yen Hsu Chen, M.D. PhD. Kaohsiung Medical University Chung-Ho Memorial Hospital
Principal Investigator: Hung Chin Tsai, M.D. PhD. Taiwan, Kaohsiung Veterans General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT02369146    
Other Study ID Numbers: UBP-A202-HIV
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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UB-421
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents