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

NCT02960581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-09-17

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 PGT121 monoclonal antibody for HIV prevention and therapy.

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

PGT121 3mg/kg IV

3mg/kg administered by IV Infusion

BIOLOGICAL

PGT121 10mg/kg IV

10mg/kg administered by IV infusion

BIOLOGICAL

PGT121 30mg/kg IV

30mg/kg administered by IV infusion

BIOLOGICAL

PGT121 3mg/kg SC

3mg/kg administered by SC injection Placebo: None

BIOLOGICAL

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

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center, Boston MA

    collaborator UNKNOWN

  • Ragon Institute of MGH, MIT and Harvard, Boston MA

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Mills Clinical Research, Los Angeles CA

    collaborator UNKNOWN

  • Orlando Immunology Clinic, Orlando FL

    collaborator UNKNOWN

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

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

  • Boris Juelg, MD PhD · Ragon Institute

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
2016-11-30
Primary Completion
2019-07-08
Completion
2019-07-08

Countries

  • United States

Study Locations

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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 NCT02960581 on ClinicalTrials.gov