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A Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGT121 Monoclonal Antibody (mAb) in HIV-uninfected and HIV-infected Adults

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ClinicalTrials.gov Identifier: NCT02960581
Recruitment Status : Enrolling by invitation
First Posted : November 9, 2016
Last Update Posted : January 3, 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 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)
Estimated Enrollment : 63 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
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 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 1
HIV-uninfected participants
 Biological: PGT121
3mg/kg administered by IV Infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 2
HIV-uninfected participants
 Biological: PGT121
10mg/kg administered by IV infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 3
HIV-uninfected participants
 Biological: PGT121
30mg/kg administered by IV infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 4
HIV-infected on ART, (<50 cp/ml)
 Biological: PGT121
3mg/kg administered by IV Infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 5
HIV-infected on ART, (<50 cp/ml)
 Biological: PGT121
10mg/kg administered by IV infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 6
HIV-infected on ART, (<50 cp/ml)
 Biological: PGT121
30mg/kg administered by IV infusion

Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Experimental: Group 7
HIV-Infected off ART (VL 2x10^3 - 1x10^5 cp/ml)
 Biological: PGT121

30mg/kg administered by IV infusion

Placebo: None
Experimental: Group 8
HIV-Infected off ART (VL 2x10^3 - 1x10^5 cp/ml)
 Biological: PGT121

10mg/kg administered by IV infusion

Placebo: None
Experimental: Group 9
HIV-Infected off ART (VL 2x10^3 - 1x10^5 cp/ml)
 Biological: PGT121

3mg/kg administered by IV infusion

Placebo: None
Experimental: Group 10
HIV-Infected off ART (VL 1x10^2 - 2x10^3 cp/ml)
 Biological: PGT121

30mg/kg administered by IV infusion

Placebo: None
Experimental: Group 11
HIV-Infected off ART (VL 1x10^2 - 2x10^3 cp/ml)
 Biological: PGT121

10mg/kg administered by IV infusion

Placebo: None
Experimental: Group 12
HIV-Infected off ART (VL 1x10^2 - 2x10^3 cp/ml)
 Biological: PGT121

3mg/kg administered by IV infusion

Placebo: None


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with PGT121 mAb 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. Impact of viral load and/or ART on PGT121 disposition elimination half-life (t1/2) [ Time Frame: 6 Months post infusion ]
  3. Change in plasma HIV-1 RNA levels from baseline (mean of pre-entry and entry values) [ Time Frame: 6 Months post infusion ]
  4. Impact of viral load and/or ART on PGT121 disposition clearance (CL/F) [ Time Frame: 6 Months post infusion ]
  5. Impact of viral load and/or ART on PGT121 disposition volume of distribution (Vz/F) [ Time Frame: 6 months post infusion ]
  6. Impact of viral load and/or ART on PGT121 disposition total exposure [ Time Frame: 6 months post infusion ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Group 1 Inclusion Criteria:

  • 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 on a stable antiretroviral regimen with HIV-1 RNA plasma level <50 copies/ml, CD4 cell count > 300 cells/uL and CD4 nadir > 200 cell/uL

Group 2 Exclusion Criteria:

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

Group 3 Inclusion Criteria:

  • HIV-infected males or females not on antiretroviral therapy for > 6 month with detectable HIV-1 RNA plasma level between 100 and 100,000 copies/ml, CD4 cell count > 300 cells/uL and CD4 nadir > 200 cell/uL

Group 3 Exclusion Criteria:

  • history of AIDS-defining illness, 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:
International AIDS Vaccine Initiative  This link exits the ClinicalTrials.gov site

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Responsible Party: International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier: NCT02960581     History of Changes
Other Study ID Numbers: IAVI T001
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Antibodies
Antibodies, Monoclonal
Antiviral Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents