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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Ragon Institute of MGH, MIT and Harvard, Boston MA | UNKNOWN |
| University of Texas Health, Houston AIDS Research Team (HART), Houston TX | UNKNOWN |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A | Experimental | HIV-uninfected participants |
|
| Group 1B | Experimental | HIV-uninfected participants |
|
| Group 1C | Experimental | HIV-uninfected participants |
|
| Group 2A | Experimental | HIV-infected on ART, (<50 cp/ml) |
|
| Group 2B | Experimental | HIV-infected on ART, (<50 cp/ml) |
|
| Group 2C |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PGT121 3mg/kg IV | Biological | 3mg/kg administered by IV Infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with PGT121 mAb reactogenicity, related AEs and SAEs | The investigators will measure the following endpoints to evaluate the safety and tolerability of PGT121 mAb in HIV-uninfected and HIV-infected adults:
| 6 Months post infusion |
| Pharmacokinetics: elimination half-life (t1/2) | Pharmacokinetics: elimination half-life (t1/2) | 6 Months post infusion |
| Pharmacokinetics: Clearance (CL/F) | Pharmacokinetics: Clearance (CL/F) | 6 Months post infusion |
| Pharmacokinetics: Volume of distribution (Vz/F) | Pharmacokinetics: Volume of distribution (Vz/F) | 6 months post infusion |
| Pharmacokinetics: Area under the concentration decay curve (AUC) | Pharmacokinetics: Area under the concentration decay curve (AUC) | 6 months post infusion |
| Pharmacokinetics: Impact of viral load and/or ART on PGT121 disposition, volume of distribution, total exposure | Pharmacokinetics: Impact of viral load and/or ART on PGT121 disposition, volume of distribution, total exposure |
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Group 1 Inclusion Criteria:
Group 1 Exclusion Criteria:
Group 2 Inclusion Criteria:
Group 2 Exclusion Criteria:
Group 3 Inclusion Criteria:
Group 3 Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Stephenson, MD MPH | Beth Israel Deaconess Medical Center, Center for Virology and Vaccine Research | Principal Investigator |
| Boris Juelg, MD PhD | Ragon Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34621054 | Derived | Stephenson KE, Julg B, Tan CS, Zash R, Walsh SR, Rolle CP, Monczor AN, Lupo S, Gelderblom HC, Ansel JL, Kanjilal DG, Maxfield LF, Nkolola J, Borducchi EN, Abbink P, Liu J, Peter L, Chandrashekar A, Nityanandam R, Lin Z, Setaro A, Sapiente J, Chen Z, Sunner L, Cassidy T, Bennett C, Sato A, Mayer B, Perelson AS, deCamp A, Priddy FH, Wagh K, Giorgi EE, Yates NL, Arduino RC, DeJesus E, Tomaras GD, Seaman MS, Korber B, Barouch DH. Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial. Nat Med. 2021 Oct;27(10):1718-1724. doi: 10.1038/s41591-021-01509-0. Epub 2021 Oct 7. |
| Label | URL |
|---|---|
| International AIDS Vaccine Initiative | View source |
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| Mills Clinical Research, Los Angeles CA | UNKNOWN |
| Orlando Immunology Clinic, Orlando FL | UNKNOWN |
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| Experimental |
HIV-infected on ART, (<50 cp/ml) |
|
| Group 3A | Experimental | HIV-Infected off ART (VL 2x10^3 - 1x10^5 cp/ml) |
|
| Group 3B | Experimental | HIV-Infected off ART (VL 1x10^2 - 2x10^3 cp/ml) |
|
| Arm 1D | Experimental | HIV-uninfected participants |
|
| 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 |
|
| 6 months post infusion |
| Antiviral Activity | Change in plasma HIV-1 RNA levels from baseline (mean of pre-entry and entry values) | 6 Months post infusion |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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