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A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults

NCT03721510 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-05-10

No results posted yet for this study

Summary

This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.

Conditions

Interventions

BIOLOGICAL

PGT121 + VRC07-523LS

PGT121 + VRC07-523LS, dose 30 mg/kg each, given intravenously

BIOLOGICAL

PGT121 + VRC07-523LS + PGDM1400

PGT121 + VRC07-523LS + PGDM1400, dose 20 mg/kg each, given intravenously

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Orlando Immunology Center

    collaborator OTHER

  • Houston AIDS Research Team

    collaborator UNKNOWN

  • International AIDS Vaccine Initiative

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2021-10-25
Completion
2022-05-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT03721510 on ClinicalTrials.gov