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 May 2019 by United BioPharma

Sponsor
United BioPharma


Information provided by (Responsible Party)
United BioPharma
ClinicalTrials.gov Identifier
NCT03164447

First received: May 21, 2017
Last updated: May 29, 2019
Last Verified: May 2019
History of Changes
Purpose

Purpose

This is a Phase 2, multi-center study, designed to evaluate the efficacy, safety, and tolerability of UB-421 in conjunction with a failing existing ART regimen for 1 week 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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-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: 10
Study Start Date: September 2019
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Multi-Drug Resistant

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:

    1. Males and females, age ≥18 years;
    2. HIV-1 seropositive, with documented HIV-1 infection by official, signed, written history (eg. Laboratory report);
    3. Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening and are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase;
    4. Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA >200 copies/ml) within the last 3 months prior to the Screening Visit;
    5. Highly treatment-experienced HIV-infected patients with documented genotypic and/or phenotypic resistance to at least one ARV drug within three or more drug classes of antiretroviral medications and have difficulty in constructing a viable suppressive regimen.
    6. Have full viral sensitivity/susceptibility to at least one approved antiretroviral agent, other than UB-421, as determined by genotypic and/or phenotypic ARV drug resistance tests at screening, and such agent can be used as a component of OBT;
    7. Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure;
    8. Have a life expectancy that is > 9 months;
    9. Laboratory values at Screening of:
        1. Absolute neutrophil count (ANC) ≥ 750/mm3;
        2. Hemoglobin (Hb) ≥ 10.5 gm/dL (male) or ≥ 9.5 gm/dL (female);
        3. Platelets ≥ 75,000 /mm3;
        4. Serum alanine transaminase (SGPT/ALT) < 2.5 x upper limit of normal (ULN);
        5. Serum aspartate transaminase (SGOT/AST) < 2.5 x ULN;
        6. Bilirubin (total) < 2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease; and
        7. Creatinine ≤ 1.5 x ULN
      1. Clinically normal resting 12-lead electrocardiogram (ECG) at the Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
      2. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants,injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy test prior to receiving the first dose of study drug; and
      3. Willing and able to participate in all aspects of the study, including use of IV medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.


    Exclusion Criteria:
      1. Any currently active AIDS-defining illness per Category C conditions according to the Center for Disease Control (CDC) Classification System for HIV Infection, with the following exceptions: local cutaneous Kaposi's sarcoma, wasting syndrome due to HIV or any other AIDS-defining illness for which no therapeutic treatment is required OR the required treatment is not included in the list of prohibited medications;
      2. Subjects with baseline liver disease including active Hepatitis B or C infection or any other active infection secondary to HIV requiring acute therapy;
      3. Subjects with baseline CD4 counts < 350 cells/mm^3.
      4. Any ≥ Grade 3 laboratory abnormality according to the division of AIDS grading scale;
      5. Unexplained fever or clinically significant illness within 2 weeks prior to the first dose of study drug;
      6. Any vaccination within 2 weeks prior to the first dose of study drug;
      7. Any immunomodulating therapy (excluding pre-medication steroid) or systemic chemotherapy within 4 weeks prior to the Screening Visit;
      8. Any radiation therapy within 4 weeks prior to the Screening Visit;
      9. Any previous exposure to monoclonal antibody for the treatment of HIV within 12 weeks prior to the Screening Visit (excluding ibalizumab);
      10. Participation in an experimental drug trial(s) within 4 weeks prior to the Screening Visit;
      11. Any prior exposure to UB-421;
      12. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study; and
      13. Any significant diseases (other than HIV-1 infection) or clinically significant
      findings that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

    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:   Allen Tsai +886-3-668-4800 ext 3641 allen.tsai@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: May 29, 2019  

    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 September 18, 2019
    This information is provided by ClinicalTrials.gov.