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

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ClinicalTrials.gov Identifier: NCT03164447
Recruitment Status : Not yet recruiting
First Posted : May 23, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
United BioPharma

Brief Summary:
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 or disease Intervention/treatment Phase
HIV-1 Infection Biological: UB-421 Drug: Optimized background therapy (OBT) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Effectiveness by Viral Load Log10 Change from Baseline [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 35 weeks ]
  2. Peak concentration of UB-421 [ Time Frame: 35 weeks ]
  3. Trough concentration of UB-421 [ Time Frame: 35 weeks ]


Information from the National Library of Medicine

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

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): 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

Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT03164447     History of Changes
Other Study ID Numbers: UBP-A205-HIV
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 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