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

NCT03205917 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-09-14

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

PGDM1400/Placebo (3mg/kg IV)

3/1 (6/2 if DLT)

BIOLOGICAL

PGDM1400/Placebo (10mg/kg IV)

3/1 (6/2 if DLT)

BIOLOGICAL

PGDM1400/Placebo (30mg/kg IV)

3/1 (6/2 if DLT)

BIOLOGICAL

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

3/1 (6/2 if DLT)

BIOLOGICAL

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

3/1 (6/2 if DLT);

BIOLOGICAL

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

3/1 (6/2 if DLT)

BIOLOGICAL

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

3 (max 9)

BIOLOGICAL

PGDM1400 + PGT121 (MTD IV)

3 (max 9)

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Ragon Institute of MGH, MIT and Harvard

    collaborator OTHER

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

    collaborator UNKNOWN

  • Orlando Immunology Clinic

    collaborator UNKNOWN

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Boris Juelg, MD, PhD · Beth Israel Deaconess Medical Center, Center for Virology and Vaccine Research, Ragon Institute of MGH, MIT and Harvard

  • Kathryn Stephenson, MD, MPH · Beth Israel Deaconess Medical Center, Center for Virology and Vaccine Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2020-04-20
Completion
2020-04-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03205917 on ClinicalTrials.gov