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Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02960581
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center, Boston MA
Ragon Institute of MGH, MIT and Harvard, Boston MA
University of Texas Health, Houston AIDS Research Team (HART), Houston TX
Mills Clinical Research, Los Angeles CA
Orlando Immunology Clinic, Orlando FL
Information provided by (Responsible Party):
International AIDS Vaccine Initiative

Study Description
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Brief Summary:
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.

Condition or disease Intervention/treatment Phase
HIV Infection Biological: PGT121 3mg/kg IV Biological: PGT121 10mg/kg IV Biological: PGT121 30mg/kg IV Biological: PGT121 3mg/kg SC Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline)) Phase 1

Detailed Description:
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy. PGT121 mAb is a recombinant human IgG1 monoclonal antibody that targets a V3 glycan-dependent epitope region of the HIV envelope protein. PGT121 mAb was chosen for this study because it is potent, neutralizes a wide array of HIV viruses, and can prevent and treat simian-human immunodeficiency virus (SHIV) in rhesus monkeys.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1 Randomized Placebo-controlled Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGT121 Monoclonal Antibody (mAb) in HIV-uninfected and HIV-infected Adults
Actual Study Start Date : November 2016
Actual Primary Completion Date : July 8, 2019
Actual Study Completion Date : July 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1A
HIV-uninfected participants
 Biological: PGT121 3mg/kg IV
3mg/kg administered by IV Infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 1B
HIV-uninfected participants
 Biological: PGT121 10mg/kg IV
10mg/kg administered by IV infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 1C
HIV-uninfected participants
 Biological: PGT121 30mg/kg IV
30mg/kg administered by IV infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 2A
HIV-infected on ART, (<50 cp/ml)
 Biological: PGT121 3mg/kg IV
3mg/kg administered by IV Infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 2B
HIV-infected on ART, (<50 cp/ml)
 Biological: PGT121 10mg/kg IV
10mg/kg administered by IV infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 2C
HIV-infected on ART, (<50 cp/ml)
 Biological: PGT121 30mg/kg IV
30mg/kg administered by IV infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 3A
HIV-Infected off ART (VL 2x10^3 - 1x10^5 cp/ml)
 Biological: PGT121 30mg/kg IV
30mg/kg administered by IV infusion
Experimental: Group 3B
HIV-Infected off ART (VL 1x10^2 - 2x10^3 cp/ml)
 Biological: PGT121 30mg/kg IV
30mg/kg administered by IV infusion
Experimental: Arm 1D
HIV-uninfected participants
 Biological: PGT121 3mg/kg SC

3mg/kg administered by SC injection

Placebo: None


Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with PGT121 mAb reactogenicity, related AEs and SAEs [ Time Frame: 6 Months post infusion ]

    The investigators will measure the following endpoints to evaluate the safety and tolerability of PGT121 mAb in HIV-uninfected and HIV-infected adults:

    1. Proportion of participants with moderate or greater reactogenicity (e.g., solicited adverse events) for 3 days following IV infusion of PGT121 mAb.
    2. Proportion of participants with moderate or greater and/or PGT121 mAb-related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, following IV infusion of PGT121 mAb for the first 56 days post administration of Investigational Product.
    3. Proportion of participants with PGT121 mAb-related serious adverse events (SAEs) throughout the study period.

  2. Pharmacokinetics: elimination half-life (t1/2) [ Time Frame: 6 Months post infusion ]
    Pharmacokinetics: elimination half-life (t1/2)

  3. Pharmacokinetics: Clearance (CL/F) [ Time Frame: 6 Months post infusion ]
    Pharmacokinetics: Clearance (CL/F)

  4. Pharmacokinetics: Volume of distribution (Vz/F) [ Time Frame: 6 months post infusion ]
    Pharmacokinetics: Volume of distribution (Vz/F)

  5. Pharmacokinetics: Area under the concentration decay curve (AUC) [ Time Frame: 6 months post infusion ]
    Pharmacokinetics: Area under the concentration decay curve (AUC)

  6. Pharmacokinetics: Impact of viral load and/or ART on PGT121 disposition, volume of distribution, total exposure [ Time Frame: 6 months post infusion ]
    Pharmacokinetics: Impact of viral load and/or ART on PGT121 disposition, volume of distribution, total exposure

  7. Antiviral Activity [ Time Frame: 6 Months post infusion ]
    Change in plasma HIV-1 RNA levels from baseline (mean of pre-entry and entry values)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Group 1 Inclusion Criteria:

  • HIV-uninfected males or females age 18-50 years old
  • Willing to maintain low risk behavior for HIV infection

Group 1 Exclusion Criteria:

  • confirmed HIV-infection, pregnancy or lactation, significant acute or chronic disease and clinically significant laboratory abnormalities

Group 2 Inclusion Criteria:

  • HIV-infected males or females age 18-65 years old
  • On a stable antiretroviral regimen with HIV-1 RNA plasma level <50 copies/ml, CD4 cell count greater than or equal to 300 cells/uL

Group 2 Exclusion Criteria:

  • history of AIDS-defining illness within the previous 5 years, significant acute or chronic medical condition other than HIV infection, and clinically significant laboratory abnormalities

Group 3 Inclusion Criteria:

  • HIV-infected males or females age 18-65
  • Not on antiretroviral therapy for > 6 months with detectable HIV-1 viral load between 100 and 100,000 copies/ml, CD4 cell count greater than or equal to 300 cells/uL

Group 3 Exclusion Criteria:

  • history of AIDS-defining illness within the previous 5 years, significant acute or chronic medical condition other than HIV infection, and clinically significant laboratory abnormalities
Contacts and Locations
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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): NCT02960581


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
International AIDS Vaccine Initiative
Beth Israel Deaconess Medical Center, Boston MA
Ragon Institute of MGH, MIT and Harvard, Boston MA
University of Texas Health, Houston AIDS Research Team (HART), Houston TX
Mills Clinical Research, Los Angeles CA
Orlando Immunology Clinic, Orlando FL
Investigators
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Principal Investigator: Kathryn Stephenson, MD MPH Beth Israel Deaconess Medical Center, Center for Virology and Vaccine Research
Study Chair: Boris Juelg, MD PhD Ragon Institute
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier: NCT02960581    
Other Study ID Numbers: IAVI T001
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases