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A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults

NCT ID: NCT03205917

Last Updated: 2020-09-14

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2020-04-20

Brief Summary

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This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGDM1400 and PGT121 and VRC07-523LS mAbs 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 PGDM1400, PGT121 and VRC07-523LS mAbs for HIV prevention and therapy. PGDM1400, PGT121 and VRC07-523LS mAbs are recombinant human IgG1 monoclonal antibodies that target V1V2 (PGDM1400), a V3 glycan-dependent epitope (PGT121) and the CD4 binding site (VRC07-523LS) epitope region of the HIV envelope protein. PGT121, PGDM1400 and VRC07-523LS mAb were chosen for this study because of their potency, their ability to neutralize a wide array of cross-clade HIV viruses in a complementary pattern and their proven antiviral activity in animal studies e.g., their capacity to robustly prevent and treat simian-human immunodeficiency virus (SHIV) in rhesus monkeys.

Conditions

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HIV Infections

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

PGDM1400 low dose

Group Type EXPERIMENTAL

PGDM1400/Placebo (3mg/kg IV)

Intervention Type BIOLOGICAL

3/1 (6/2 if DLT)

Group 1B HIV-Uninfected

PGDM1400 mid dose

Group Type EXPERIMENTAL

PGDM1400/Placebo (10mg/kg IV)

Intervention Type BIOLOGICAL

3/1 (6/2 if DLT)

Group 1C HIV-Uninfected

PGDM1400 high dose

Group Type EXPERIMENTAL

PGDM1400/Placebo (30mg/kg IV)

Intervention Type BIOLOGICAL

3/1 (6/2 if DLT)

Group 2A HIV-Uninfected

PGDM1400 + PGT121 low dose

Group Type EXPERIMENTAL

PGDM1400 + PGT121/Placebo (3mg/kg + 3mg/kg IV)

Intervention Type BIOLOGICAL

3/1 (6/2 if DLT)

Group 2B HIV-Uninfected

PGDM1400 + PGT121 mid dose

Group Type EXPERIMENTAL

PGDM1400 + PGT121/Placebo (10mg/kg + 10mg/kg IV)

Intervention Type BIOLOGICAL

3/1 (6/2 if DLT);

Group 2C HIV-Uninfected

PGDM1400 + PGT121 high dose

Group Type EXPERIMENTAL

PGDM1400 + PGT121/Placebo (30mg/kg + 30mg/kg IV)

Intervention Type BIOLOGICAL

3/1 (6/2 if DLT)

Group 3A HIV-infected off ART

PGDM1400 + PGT121 + VRC07-523LS at 20mg/kg; HIV+ without ART

Group Type EXPERIMENTAL

PGDM1400 + PGT121 + VRC07-523LS (20mg/kg + 20mg/kg + 20 mg/kg IV)

Intervention Type BIOLOGICAL

3 (max 9)

Group 3B HIV-infected off ART

PGDM1400 + PGT121 at high dose; HIV + without ART

Group Type EXPERIMENTAL

PGDM1400 + PGT121 (MTD IV)

Intervention Type BIOLOGICAL

3 (max 9)

Interventions

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PGDM1400/Placebo (3mg/kg IV)

3/1 (6/2 if DLT)

Intervention Type BIOLOGICAL

PGDM1400/Placebo (10mg/kg IV)

3/1 (6/2 if DLT)

Intervention Type BIOLOGICAL

PGDM1400/Placebo (30mg/kg IV)

3/1 (6/2 if DLT)

Intervention Type BIOLOGICAL

PGDM1400 + PGT121/Placebo (3mg/kg + 3mg/kg IV)

3/1 (6/2 if DLT)

Intervention Type BIOLOGICAL

PGDM1400 + PGT121/Placebo (10mg/kg + 10mg/kg IV)

3/1 (6/2 if DLT);

Intervention Type BIOLOGICAL

PGDM1400 + PGT121/Placebo (30mg/kg + 30mg/kg IV)

3/1 (6/2 if DLT)

Intervention Type BIOLOGICAL

PGDM1400 + PGT121 + VRC07-523LS (20mg/kg + 20mg/kg + 20 mg/kg IV)

3 (max 9)

Intervention Type BIOLOGICAL

PGDM1400 + PGT121 (MTD IV)

3 (max 9)

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
* Not on antiretroviral therapy with HIV-1 RNA plasma level between 1,000 and 100,000 copies/ml, CD4 cell count ≥ 300 cells/uL

Exclusion Criteria

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


• 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

OTHER

Sponsor Role collaborator

Ragon Institute of MGH, MIT and Harvard

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Orlando Immunology Clinic

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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Boris Juelg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center, Center for Virology and Vaccine Research, Ragon Institute of MGH, MIT and Harvard

Kathryn Stephenson, MD, MPH

Role: STUDY_CHAIR

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

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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Julg B, Stephenson KE, Wagh K, Tan SC, Zash R, Walsh S, Ansel J, Kanjilal D, Nkolola J, Walker-Sperling VEK, Ophel J, Yanosick K, Borducchi EN, Maxfield L, Abbink P, Peter L, Yates NL, Wesley MS, Hassell T, Gelderblom HC, deCamp A, Mayer BT, Sato A, Gerber MW, Giorgi EE, Gama L, Koup RA, Mascola JR, Monczor A, Lupo S, Rolle CP, Arduino R, DeJesus E, Tomaras GD, Seaman MS, Korber B, Barouch DH. Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a phase 1 clinical trial. Nat Med. 2022 Jun;28(6):1288-1296. doi: 10.1038/s41591-022-01815-1. Epub 2022 May 12.

Reference Type DERIVED
PMID: 35551291 (View on PubMed)

Related Links

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http://iavi.org

IAVI Website

Other Identifiers

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IAVI T002

Identifier Type: -

Identifier Source: org_study_id

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