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NCT Number: NCT02960581

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

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PGT121 3mg/kg IV

Biological

3mg/kg administered by IV Infusion

PGT121 10mg/kg IV

Biological

10mg/kg administered by IV infusion

PGT121 30mg/kg IV

Biological

30mg/kg administered by IV infusion

PGT121 3mg/kg SC

Biological

3mg/kg administered by SC injection

Placebo: None

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

Biological

Primary outcomes

  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:

    • Proportion of participants with moderate or greater reactogenicity (e.g., solicited adverse events) for 3 days following IV infusion of PGT121 mAb.
    • 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.
    • 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)

Sponsors and collaborators

Lead sponsor

International AIDS Vaccine Initiative

Network

Collaborators

  • Beth Israel Deaconess Medical Center
  • Mills Clinical Research, Los Angeles CA
  • Orlando Immunology Clinic, Orlando FL
  • Ragon Institute of MGH, MIT and Harvard, Boston MA
  • University of Texas Health, Houston AIDS Research Team (HART), Houston TX

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2016
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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