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To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults

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ClinicalTrials.gov Identifier: NCT03149211
Recruitment Status : Not yet recruiting
First Posted : May 11, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
United BioPharma

Brief Summary:
The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing antiretroviral treatment interruption.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: UB-421 Drug: current standard HAART treatment Phase 3

Detailed Description:
This is an open-label, Phase III study to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound while replace HAART in virally suppressed HIV-1 infected adults. In this study, approximately 375 subjects on stable HAART treatment will be randomized to receive either continuing HAART treatment alone (Cohort 1) or UB-421 as the monotherapy (Cohort 2) in 1:2 ratio. For Cohort 1, subjects will receive current standard HAART treatment as the active control group. For Cohort 2, UB-421 will be administered to enrolled subjects without HAART treatment in the Cohort 2 during the 26-week treatment period. After treatment period, both cohort 1 and cohort 2 enter 22-week follow-up period.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-label, Controlled Trial to Investigate the Efficacy and Safety of UB-421 Monotherapy as Substitution for Stable Antiretroviral Therapy in HIV-1 Infected Adults
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Cohort 1
Subjects will receive current standard HAART treatment as the active control group.
Drug: current standard HAART treatment
Subjects will receive current standard HAART treatment as the active control group.

Experimental: Cohort 2
Subjects will receive UB-421 without HAART treatment by intravenous infusion at 25 mg/kg bi-weekly. After 26-week treatment period, subjects will enter 22-week follow-up period with current standard HAART treatment.
Drug: UB-421
Subjects will receive 13 doses of the UB-421 by intravenous infusion at 25 mg/kg bi-weekly (Cohort 2, 26 weeks).
Other Name: dB4C7 mAb

Drug: current standard HAART treatment
Subjects will receive current standard HAART treatment as the active control group.




Primary Outcome Measures :
  1. Number of participants without virologic failure [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Time to virologic failure [ Time Frame: 26 weeks ]
  2. Number of participants with treatment-related adverse events [ Time Frame: 48 weeks ]
  3. Peak concentration of UB-421 in Cohort 2 [ Time Frame: 30 weeks ]
  4. Trough concentration of UB-421 in Cohort 2 [ Time Frame: 30 weeks ]


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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
  • 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 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
  • Life expectancy less than 12 months
  • Any alcohol or illicit drug used, according to the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations

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): NCT03149211


Contacts
Contact: Jessica Cheng +886-3-668-4800 ext 3613 jessica.cheng@unitedbiopharma.com
Contact: Annie Lai +886-3-668-4800 ext 3614 annie.lai@unitedbiopharma.com

Sponsors and Collaborators
United BioPharma

Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT03149211     History of Changes
Other Study ID Numbers: UBP-A304-HIV
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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