This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 May 2017 by United BioPharma
Sponsor:
Information provided by (Responsible Party):
United BioPharma
ClinicalTrials.gov Identifier:
NCT03164447
First received: May 21, 2017
Last updated: NA
Last verified: May 2017
History: No changes posted
  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

Resource links provided by NLM:


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 2017
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: May 2019 (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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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

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: May 21, 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017