Clinical Trials

MainTitle

UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients

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
NCT03164447

First received: May 21, 2017
Last updated: October 24, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

This study evaluates the efficacy, safety, and tolerability of UB-421 in conjunction with an existing failing antiretroviral therapy (ART) for 2 weeks and optimized background therapy (OBT) for 24 weeks, respectively.

Condition Intervention Phase
HIV-1 Infection

Biological : UB-421
Drug : Optimized background therapy (OBT)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Parallel-Arm, 24-Week Study of UB-421 in Combination With Optimized Background Therapy (OBT) Regimen in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection

Further study details as provided by United BioPharma:

Primary Outcome Measures

  • Effectiveness by Viral Load Log10 Change from Baseline [ Time Frame: 2 weeks ]
Secondary Outcome Measures:
  • Number of participants with treatment-related adverse events [ Time Frame: 35 weeks ]
  • Peak concentration of UB-421 [ Time Frame: 35 weeks ]
  • Trough concentration of UB-421 [ Time Frame: 35 weeks ]

Estimated Enrollment: 30
Anticipated Study Start Date: September 2018
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Cohort 1

Biological: UB-421

Monoclonal antibody by IV infusion

Drug: Optimized background therapy (OBT)

The prescribed OBT must contain at least one agent to which the participant's virus is known to be fully sensitive.

Experimental: Cohort 2

Biological: UB-421

Monoclonal antibody by IV infusion

Drug: Optimized background therapy (OBT)

The prescribed OBT must contain at least one agent to which the participant's virus is known to be fully sensitive.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • HIV-1 sero-positive
  • Receiving combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening
  • Have a life expectancy that is > 6 months
  • Subjects agree on using birth control barrier (female or male condom) during the entire study period
  • Willing and able to participate in all aspects of the study


Exclusion Criteria:
  • Any prior exposure to UB-421
  • Any active infection secondary to HIV requiring acute therapy
  • Any significant diseases (other than HIV-1 infection) or clinically significant findings
  • Any immunomodulating therapy (excluding pre-medication steroid) or systemic chemotherapy within 4 weeks prior to the Screening Visit
  • Any vaccination within 2 weeks prior to the first dose of study drug

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: NCT03164447

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: NCT03164447   History of Changes  
Other Study ID Numbers: UBP-A205-HIV  
Study First Received: May 21, 2017  
Last Updated: October 24, 2017  

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections

ClinicalTrials.gov processed this data on December 12, 2017
This information is provided by ClinicalTrials.gov.