Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified October 2017 by United BioPharma

Sponsor
United BioPharma


Information provided by (Responsible Party)
United BioPharma
ClinicalTrials.gov Identifier
NCT03149211

First received: May 2, 2017
Last updated: October 24, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV-1 Infection

Drug : UB-421
Drug : current standard HAART treatment
Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by United BioPharma:

Primary Outcome Measures

  • Number of participants without virologic failure [ Time Frame: 24 weeks ]
Secondary Outcome Measures:
  • Time to virologic failure [ Time Frame: 26 weeks ]
  • Number of participants with treatment-related adverse events [ Time Frame: 48 weeks ]
  • Peak concentration of UB-421 in Cohort 2 [ Time Frame: 30 weeks ]
  • Trough concentration of UB-421 in Cohort 2 [ Time Frame: 30 weeks ]

Estimated Enrollment: 375
Anticipated Study Start Date: September 2018
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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.

Eligibility

Eligibility

Ages Eligible for Study: 20 Years and older  
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

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: NCT03149211

Contacts

Contact:   Rayla Liu +886-3-668-4800 ext 3616 rayla.liu@unitedbiopharma.com
Contact:   Annie Lai +886-3-668-4800 ext 3614 annie.lai@unitedbiopharma.com

Sponsors and Collaborators

United BioPharma
More Information

More Information


Responsible Party: United BioPharma  
ClinicalTrials.gov Identifier: NCT03149211   History of Changes  
Other Study ID Numbers: UBP-A304-HIV  
Study First Received: May 2, 2017  
Last Updated: October 24, 2017  

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

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.