← Back to Search

Monoclonal Antibodies

VRC07-523LS (20mg/kg, IV) for Human Immunodeficiency Virus Infection

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 40

Awards & highlights

No Placebo-Only Group

Summary

This trial tests lab-made antibodies to help people at risk of or with HIV. The antibodies are designed to help the immune system recognize and fight the virus. Researchers are checking if these antibodies are safe and effective when given in different ways.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
HIV Suppression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Magnitude of serum neutralizing activity (ie, neutralizing antibody titers, including ID50, ID80) measured with monoclonal antibody mAb-specific Env-pseudotyped viruses in TZM-bl cells (in the validated TZM-bl pseudovirus neutralization assay) for Part A

Percentage of participants who experience local solicited adverse events (AEs) in Part A

+9 more

Secondary study objectives

Anti-drug antibodies (ADA) titers for participants in Part A

Anti-drug antibodies (ADA) titers for participants in Part B

Magnitude of neutralizing activity (i.e., neutralizing antibody titers, including ID50 and ID80) against a panel of Env-pseudotyped reference viruses in TZM-bl cells (in the validated TZM-bl pseudovirus neutralization assay) for participants in Part B

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups

Experimental Treatment

Group I: PGDM1400LS 5 mg/kg IVExperimental Treatment1 Intervention

Participants will receive PGDM1400LS 5 mg/kg by intravenous (IV) infusion at Month 0

Group II: PGDM1400LS 40mg/kg + VRC07-523LS 40mg/kg + PGT121.414.LS 40 mg/kg IVExperimental Treatment3 Interventions

Participants will receive PGDM1400LS 40mg/kg + VRC07-523LS 40mg/kg + PGT121.414.LS 40 mg/kg by IV infusion sequentially in this order at Month 0 and Month 4

Group III: PGDM1400LS 40 mg/kg SCExperimental Treatment1 Intervention

Participants will receive PGDM1400LS 40 mg/kg by SC infusion at Month 0

Group IV: PGDM1400LS 40 mg/kg IVExperimental Treatment1 Intervention

Participants will receive PGDM1400LS 40 mg/kg by IV infusion at Month 0

Group V: PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg SCExperimental Treatment3 Interventions

Participants will receive PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg by SC infusion sequentially in this order at Month 0 and Month 4

Group VI: PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg IVExperimental Treatment3 Interventions

Participants will receive PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg by IV infusion sequentially in this order at Month 0 and Month 4

Group VII: PGDM1400LS 20 mg/kg SCExperimental Treatment1 Intervention

Participants will receive PGDM1400LS 20 mg/kg by subcutaneous (SC) infusion at Month 0

Group VIII: PGDM1400LS 20 mg/kg IVExperimental Treatment1 Intervention

Participants will receive PGDM1400LS 20 mg/kg by IV infusion at Month 0

Group IX: PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram SCExperimental Treatment3 Interventions

Participants will receive PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram by SC infusion sequentially in this order at Month 0 and Month 4

Group X: PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram IVExperimental Treatment3 Interventions

Participants will receive PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram by IV infusion sequentially in this order at Month 0 and Month 4

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PGT121.414.LS (1.4g, IV)

2021

Completed Phase 1

~100

PGT121.414.LS (1.4g, SC)

2021

Completed Phase 1

~100