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Monoclonal Antibodies

Group 1 for HIV

Phase 1 & 2
Waitlist Available
Research Sponsored by International AIDS Vaccine Initiative
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 92 weeks
Awards & highlights

Study Summary

This trial is testing two different antibodies to see if they are safe for healthy adults and if they can maintain levels in the bloodstream.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~92 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 92 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1. Proportion of participants with solicited and treatment-related unsolicited adverse events and their duration.
Proportion of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and their duration.
Serum concentration of each antibody in each group at multiple timepoints along with participant characteristics (e.g. sex, weight, and BMI)
+1 more
Secondary outcome measures
Serum concentration of anti-10-1074-LS-J antibodies in each group at multiple timepoints.
Serum concentration of anti-3BNC117-LS-J antibodies in each group at multiple timepoints.

Trial Design

10Treatment groups
Experimental Treatment
Group I: Group 9Experimental Treatment2 Interventions
Subcutaneous injection in abdomen combined ratio 2 without loading dose 30:3 ratio of Ab:Placebo
Group II: Group 8Experimental Treatment2 Interventions
Subcutaneous injection in abdomen combined ratio 3 with loading dose 30:3 ratio of Ab:Placebo
Group III: Group 7Experimental Treatment2 Interventions
Subcutaneous injection in abdomen combined ratio 2 with loading dose 30:3 ratio of Ab:Placebo
Group IV: Group 6Experimental Treatment2 Interventions
Subcutaneous injection combined ratio 1 with loading dose 30:3 ratio of Ab:Placebo
Group V: Group 5Experimental Treatment2 Interventions
Combined agent intravenous injection 10:2 ratio for Ab:placebo
Group VI: Group 4Experimental Treatment2 Interventions
Single agent intravenous injection 10:2 ratio for Ab:placebo
Group VII: Group 3Experimental Treatment2 Interventions
Single agent intravenous injection 10:2 ratio for Ab:placebo
Group VIII: Group 2Experimental Treatment2 Interventions
Single agent, abdominal subcutaneous injection 10:2 ratio for Ab:placebo
Group IX: Group 10Experimental Treatment2 Interventions
Subcutaneous injection in arm combined ratio 2 without loading dose 30:3 ratio of Ab:Placebo
Group X: Group 1Experimental Treatment2 Interventions
Single Agent, abdominal subcutaneous injection, 10:2 ratio for Ab:placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Fred Hutchinson Cancer CenterOTHER
556 Previous Clinical Trials
1,343,043 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,611 Previous Clinical Trials
11,470,294 Total Patients Enrolled
Rockefeller UniversityOTHER
158 Previous Clinical Trials
16,132 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults
2019. "Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04173819.
~36 spots leftby Apr 2025
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