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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

Study Summary

This trial is testing a new HIV antibody to see how the body's immune system responds to it, as well as to study safety and tolerability. The trial will be conducted in two parts, with Part A testing different doses and ways of administering the antibody, and Part B testing different combinations of the antibody.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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 B
Percentage of participants who discontinue study product administration early in Part A
+13 more
Secondary outcome measures
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

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 (20mg/kg, SC)
2021
Completed Phase 1
~100
PGT121.414.LS (1.4g, IV)
2021
Completed Phase 1
~100
PGDM1400LS (20mg/kg, SC)
2021
Completed Phase 1
~100
PGT121.414.LS (1.4g, SC)
2021
Completed Phase 1
~100
PGT121.414.LS (20mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (5mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (20mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (1.4g, SC)
2021
Completed Phase 1
~100
VRC07-523LS (1.4g, SC)
2021
Completed Phase 1
~100
VRC07-523LS (40mg/kg, IV)
2021
Completed Phase 1
~100
PGT121.414.LS (40mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (40mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (40mg/kg, SC)
2021
Completed Phase 1
~100
VRC07-523LS (20mg/kg, SC)
2021
Completed Phase 1
~100
VRC07-523LS (20mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (1.4g, IV)
2021
Completed Phase 1
~100
VRC07-523LS (1.4g, IV)
2021
Completed Phase 1
~100

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,854 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,142 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,755 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Massachusetts
California
How old are they?
18 - 65
What site did they apply to?
Bridge HIV CRS
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants
2021. "A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05184452.
~28 spots leftby Apr 2025
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