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Albuvirtide in Combination With 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection

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ClinicalTrials.gov Identifier: NCT04819347
Recruitment Status : Not yet recruiting
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Frontier Biotechnologies Inc.

Tracking Information
First Submitted Date  ICMJE March 22, 2021
First Posted Date  ICMJE March 26, 2021
Last Update Posted Date March 26, 2021
Estimated Study Start Date  ICMJE May 1, 2021
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
Proportion of participants (with sustained viral suppression at week 14) with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI) [ Time Frame: Week 26 ]
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • Mean time to virologic rebound (HIV-1 RNA≥200 copies/mL) after ATI [ Time Frame: up to 48 weeks ]
    Mean time to virologic rebound
  • Proportion of participants without experiencing virologic rebound (HIV-1 RNA<200 copies/mL) at Week 26 (24 weeks after ATI). [ Time Frame: Week 26 ]
    Proportion of participants without experiencing virologic rebound
  • Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI). [ Time Frame: Week 26 ]
    Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26
  • Mean change in CD4 cell count after ATI [ Time Frame: up to 48 weeks ]
    Mean change in CD4 cell count
  • Mean change in CD4/CD8 ration after ATI [ Time Frame: up to 48weeks ]
    Mean change in CD4/CD8 ration
  • Frequency of emergence of new resistance mutations after virologic rebound [ Time Frame: up to 48 weeks ]
    Frequency of emergence of new resistance mutations
  • Mean time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound [ Time Frame: up to 48 weeks ]
    Mean time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Albuvirtide in Combination With 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection
Official Title  ICMJE The Phase 2, Two Arms, One Site, Safety and Antiviral Activity of Combination Therapy With Albuvirtide and 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection After Analytical Treatment Interruption
Brief Summary This is a phase 2 study to evaluate the safety and tolerability of combination therapy with Albuvirtide (ABT) and 3BNC117 in virologically suppressed subjects with HIV-1 infection and explore the potential of viral suppression and viral reservoir clearance after analytical treatment interruption (ATI).
Detailed Description

This is an open-label, one site study, in which a total of 24 HIV-1 subjects who are virologically suppressed and stable on daily oral combination antiretroviral therapy will be enrolled.

All eligible patients will be switched from daily oral combination antiretroviral regimen to treatment of ABT and 3BNC117 for 14 weeks. There is a two-week overlap of the baseline oral antiretroviral therapy and the ABT-3BNC117 combination regimen at the beginning of the study treatment, and then the oral ART will be interrupted.

The patients will be monitored for viral rebound every two or four weeks following initiation of ABT-3BNC117 combination and will re-initiate an oral antiretroviral regimen if virological rebound is confirmed with plasma HIV-1 RNA levels above 200 copies/ml on two consecutive test.

Pharmacokinetics of ABT and 3BNC117 will be assessed in this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • Drug: Albuvirtide
    Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
    Other Name: ABT
  • Drug: 3BNC117
    Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120.
Study Arms  ICMJE
  • Experimental: Early treatment of infection

    HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) within 6 months of primary HIV infection (PHI), and had plasma HIV-1 RNA <50 copies/mL for at least 12 months.

    Albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks IV infusion for a total of 14 weeks.

    Interventions:
    • Drug: Albuvirtide
    • Drug: 3BNC117
  • Experimental: Chronic period of infection treatment

    Chronically HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) after 6 months of primary HIV infection (PHI), and had plasma HIV-1 RNA <50 copies/mL for at least 12 months.

    Albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks IV infusion for a total of 14 weeks.

    Interventions:
    • Drug: Albuvirtide
    • Drug: 3BNC117
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2021)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females, age ≥18 years
  2. For cohort 1: HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) within 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy within 6 months of PHI.

    For cohort 2: Chronically HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) after 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy after 6 months of PHI.

  3. Plasma HIV-1 RNA <50 copies/mL for at least 12 months prior to Screening Visit. An exception for a recorded HIV-1 RNA "blip" (e.g., transient HIV-1 RNA >50 copies/mL) can be considered.
  4. Plasma HIV-1 RNA <20 copies/mL at Screening Visit.
  5. CD4 cell count >500 cells/µL.
  6. Laboratory values at Screening of:

    1. Absolute neutrophil count (ANC) ≥0.75×10∧9/L;
    2. Hemoglobin (Hb) ≥105 g/L (male) or ≥95 g/L (female);
    3. Platelets ≥75×10∧9/L;
    4. Serum alanine transaminase (SGPT/ALT) < 2 x upper limit of normal (ULN)
    5. Serum aspartate transaminase (SGOT/AST) < 2 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
    7. Creatinine ≤1.5 x ULN
  7. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
  8. Both male and female patients and their partners of childbearing potential must agree to use accepted methods of contraception.
  9. Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
  10. Subjects who have two or more potential alternative antiretroviral treatment regimens.
  11. Willing and able to participate in all aspects of the study, including use of IV medication, completion of evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria:

  1. Any active infection or malignancy requiring acute therapy.
  2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg).
  3. Hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening.
  4. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  5. Unexplained fever or clinically significant illness within 1 week prior to the first study dose
  6. Any vaccination within 2 weeks prior to the first study dose.
  7. Subjects BMI<20 or >27 kg/m∧2 [BMI=weight/height∧2].
  8. History of Bleeding Disorder or patients on anti-coagulant therapy
  9. Participation in an experimental drug trial(s) within 30 days of the Screening Visit
  10. Any known allergy or antibodies to the study drug or excipients
  11. Treatment with any of the following:

    1. Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
    2. Receipt of any fusion inhibitor and monoclonal antibody therapy of any kind in the past.
    3. Immunosuppressants within 60 days prior to the Screening Visit
    4. Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit
    5. Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception:
    6. Subjects on inhaled, nasal, or topical steroids will not be excluded
  12. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xingxiang Xu 025-69648410 xxxu@frontierbiotech.com
Contact: Cheng Yao yaocheng@frontierbiotech.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04819347
Other Study ID Numbers  ICMJE ABT-3BNC117_202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Frontier Biotechnologies Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Frontier Biotechnologies Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cheng Yao Frontier Biotechnologies Inc.
PRS Account Frontier Biotechnologies Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP