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

NCT ID: NCT02960581

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-07-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1A

HIV-uninfected participants

Group Type EXPERIMENTAL

PGT121 3mg/kg IV

Intervention Type BIOLOGICAL

3mg/kg administered by IV Infusion

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

Intervention Type BIOLOGICAL

Group 1B

HIV-uninfected participants

Group Type EXPERIMENTAL

PGT121 10mg/kg IV

Intervention Type BIOLOGICAL

10mg/kg administered by IV infusion

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

Intervention Type BIOLOGICAL

Group 1C

HIV-uninfected participants

Group Type EXPERIMENTAL

PGT121 30mg/kg IV

Intervention Type BIOLOGICAL

30mg/kg administered by IV infusion

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

Intervention Type BIOLOGICAL

Group 2A

HIV-infected on ART, (\<50 cp/ml)

Group Type EXPERIMENTAL

PGT121 3mg/kg IV

Intervention Type BIOLOGICAL

3mg/kg administered by IV Infusion

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

Intervention Type BIOLOGICAL

Group 2B

HIV-infected on ART, (\<50 cp/ml)

Group Type EXPERIMENTAL

PGT121 10mg/kg IV

Intervention Type BIOLOGICAL

10mg/kg administered by IV infusion

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

Intervention Type BIOLOGICAL

Group 2C

HIV-infected on ART, (\<50 cp/ml)

Group Type EXPERIMENTAL

PGT121 30mg/kg IV

Intervention Type BIOLOGICAL

30mg/kg administered by IV infusion

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

Intervention Type BIOLOGICAL

Group 3A

HIV-Infected off ART (VL 2x10\^3 - 1x10\^5 cp/ml)

Group Type EXPERIMENTAL

PGT121 30mg/kg IV

Intervention Type BIOLOGICAL

30mg/kg administered by IV infusion

Group 3B

HIV-Infected off ART (VL 1x10\^2 - 2x10\^3 cp/ml)

Group Type EXPERIMENTAL

PGT121 30mg/kg IV

Intervention Type BIOLOGICAL

30mg/kg administered by IV infusion

Arm 1D

HIV-uninfected participants

Group Type EXPERIMENTAL

PGT121 3mg/kg SC

Intervention Type BIOLOGICAL

3mg/kg administered by SC injection

Placebo: None

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

Intervention Type BIOLOGICAL

Interventions

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PGT121 3mg/kg IV

3mg/kg administered by IV Infusion

Intervention Type BIOLOGICAL

PGT121 10mg/kg IV

10mg/kg administered by IV infusion

Intervention Type BIOLOGICAL

PGT121 30mg/kg IV

30mg/kg administered by IV infusion

Intervention Type BIOLOGICAL

PGT121 3mg/kg SC

3mg/kg administered by SC injection

Placebo: None

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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


* 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


* 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

Exclusion Criteria

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


* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beth Israel Deaconess Medical Center, Boston MA

UNKNOWN

Sponsor Role collaborator

Ragon Institute of MGH, MIT and Harvard, Boston MA

UNKNOWN

Sponsor Role collaborator

University of Texas Health, Houston AIDS Research Team (HART), Houston TX

UNKNOWN

Sponsor Role collaborator

Mills Clinical Research, Los Angeles CA

UNKNOWN

Sponsor Role collaborator

Orlando Immunology Clinic, Orlando FL

UNKNOWN

Sponsor Role collaborator

International AIDS Vaccine Initiative

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Stephenson, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center, Center for Virology and Vaccine Research

Boris Juelg, MD PhD

Role: STUDY_CHAIR

Ragon Institute

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34621054 (View on PubMed)

Related Links

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http://iavi.org

International AIDS Vaccine Initiative

Other Identifiers

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IAVI T001

Identifier Type: -

Identifier Source: org_study_id

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