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Monoclonal Antibodies

PGT121.414.LS 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
General and Demographic Criteria
Age of 18 to 50 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through participant's last study visit at month 6-16, depending on which arm they are in
Awards & highlights

Study Summary

This trial is testing an HIV antibody to see if it's safe, tolerable, and effective when given alone or with another HIV antibody.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through participant's last study visit at month 6-16, depending on which arm they are in
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through participant's last study visit at month 6-16, depending on which arm they are in 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 measured with monoclonal antibody (mAb)-specific Env-pseudotyped viruses in TZM-bl cells
Percentage of participants who discontinue study product administration early
Percentage of participants who experience local solicited adverse events (AEs)
+4 more
Secondary outcome measures
Anti-drug antibodies (ADA) titers
Magnitude of neutralizing activity against a panel of Env pseudotyped reference viruses in TZM-bl cells
Magnitude of neutralizing activity against a panel of Env-pseudotyped reference viruses in TZM-bl cells
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part B (Group 6): PGT121.414.LS + VRC07-523LS (5 mg/kg)Experimental Treatment2 Interventions
Participants will receive 5 mg/kg of PGT121.414.LS and 5 mg/kg of VRC07-523LS by SC infusion sequentially in this order at Months 0, 4, and 8.
Group II: Part B (Group 5): PGT121.414.LS + VRC07-523LS (20 mg/kg)Experimental Treatment2 Interventions
Participants will receive 20 mg/kg of PGT121.414.LS and 20 mg/kg of VRC07-523LS by IV infusion sequentially in this order at Months 0, 4, and 8.
Group III: Part A (Group 4): PGT121.414.LS (5 mg/kg)Experimental Treatment1 Intervention
Participants will receive 5 mg/kg of PGT121.414.LS by subcutaneous (SC) infusion at Month 0.
Group IV: Part A (Group 3): PGT121.414.LS (30 mg/kg)Experimental Treatment1 Intervention
Participants will receive 30 mg/kg of PGT121.414.LS by IV infusion at Month 0.
Group V: Part A (Group 2): PGT121.414.LS (10 mg/kg)Experimental Treatment1 Intervention
Participants will receive 10 mg/kg of PGT121.414.LS by IV infusion at Month 0.
Group VI: Part A (Group 1): PGT121.414.LS (3 mg/kg)Experimental Treatment1 Intervention
Participants will receive 3 mg/kg of PGT121.414.LS by intravenous (IV) infusion at Month 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PGT121.414.LS
2020
Completed Phase 1
~40
VRC07-523LS
2019
Completed Phase 1
~310

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,482,973 Total Patients Enrolled
HIV Vaccine Trials NetworkNETWORK
39 Previous Clinical Trials
10,724 Total Patients Enrolled
HIV Prevention Trials NetworkNETWORK
30 Previous Clinical Trials
568,671 Total Patients Enrolled

Frequently Asked Questions

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

Is eligibility limited to individuals under the age of 45 for this research endeavor?

"Eligible patients for this study must be between the age of majority and 50 years old."

Answered by AI

Are recruitment efforts for this experiment ongoing?

"The information on clinicaltrials.gov shows that this particular trial has concluded its recruitment phase and is no longer accepting patients. It was initially posted in October 2020, with the last update occurring at the end of August 2022; however, there are still 484 other trials actively recruiting right now."

Answered by AI

What is the number of locations participating in this experiment?

"This clinical research is occurring at George Washington University in the District of Columbia, The Hope Clinic of Emory Vaccine Center in Decatur, Georgia, and UCLA CARE Centre in Los Angeles. Additionally there are 6 additional sites running this trial."

Answered by AI

Might I be eligible to join this clinical trial?

"This clinical trial is looking to enrol 32 participants who have HIV and are aged between 18-50. To qualify, they must be willing to discuss HIV infection risks and partake in risk reduction counselling; demonstrate general good health through medical history, physical exam and screening lab tests; receive their HIV test results; as well as commit to a low-risk behaviour until the last required protocol clinic visit. Additionally, no other investigational research agent can be enrolled in until completion of this study's final visits."

Answered by AI

What is the intended outcome of this research?

"The primary endpoint of this trial will be assessed by Month 8 and is the magnitude of serum neutralizing activity, as measured with monoclonal antibody (mAb)-specific Env-pseudotyped viruses in TZM-bl cells. Secondary objectives include measuring the magnitude of neutralising activity against a panel of reference virus pseudotypes in TZM-bl cells at specified timepoints for participants from all groups; assessing serum concentrations of VRC07-523LS at prearranged intervals; and also recording Anti-drug antibodies (ADA) titres during predetermined times for every participant regardless how many product administrations they have received"

Answered by AI

Has the FDA authorized PGT121.414.LS for public consumption?

"With minimal data verifying PGT121.414.LS's safety and efficacy this medication garnered a score of 1 on our team's rating scale from 1 to 3."

Answered by AI
~8 spots leftby Mar 2025