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Monoclonal Antibodies

10E8.4/iMab for HIV

Phase 1
Waitlist Available
Led By David D. Ho, MD
Research Sponsored by David Ho
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy volunteers born male and female as assessed by medical history and physical examination
Aged >18 and <60 years at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and works against HIV infection. The study will be conducted at two sites and will test the drug in HIV-infected and HIV-uninfected people.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The text states that healthy volunteers are those who are male and female as assessed by medical history and physical examination.
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Between the ages of 18 and 60 years old.
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was high The study found that the willingness to comply with the study protocol was high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Injection site reactions associated with a single subcutaneous injection of 10 E8.4/iMab in HIV uninfected individuals
Safety of the highest single intravenous dose of 10E8.4/iMab in HIV infected individuals Safety of a single dose of intravenous dose of 10E8.4/iMab in HIV uninfected individuals
Safety of the highest single intravenous dose of 10E8.4/iMab in HIV uninfected individuals. Safety of a single dose of intravenous dose of 10E8.4/iMab in HIV uninfected individuals
+1 more
Secondary outcome measures
Antiviral activity of the highest single dose of 10E8.4/iMab given intravenously to viremic HIV infected individuals
Percentage of subjects developing antibodies to 10E8.4/iMab after any single intravenous or subcutaneous dose of 10E8.4/iMab
Serum levels 10E8.4/iMab after the highest single dose of 10E8.4/iMab given intravenously to HIV infected and uninfected individuals
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 4: 10E8.4/iMab SC HIV-Experimental Treatment1 Intervention
Arm 4; Groups J and K: HIV-uninfected individuals
Group II: Arm 3 and 3a: 10E8.4/iMab IV HIV+Experimental Treatment1 Intervention
Arm 3; Group H; 1 dosing group: HIV-infected individuals with HIV-1 RNA levels between 1,000 and 100,000 copies/mL and cluster of differentiation 4 (CD4)>350 cells/mm3; Arm 3a; Group I; 1 dosing group: HIV-infected and suppressed individuals
Group III: Arm 2: 10E8.4/iMab IV HIV-Experimental Treatment1 Intervention
Arm 2; Groups D-F; 3 dosing groups: HIV-uninfected individuals
Group IV: Arm 1: 10E8.4/iMab IV or SC HIV-Experimental Treatment1 Intervention
Arm 1; Groups A-C; 3 dosing groups: HIV-uninfected individuals
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
10E8.4/iMab
2019
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

David HoLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Bill and Melinda Gates FoundationOTHER
406 Previous Clinical Trials
19,624,037 Total Patients Enrolled
International AIDS Vaccine InitiativeNETWORK
48 Previous Clinical Trials
13,206 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?
Georgia
Florida
How old are they?
18 - 65
What site did they apply to?
Orlando Immunology Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
AidsJournal
Prevalence of Broadly Neutralizing Antibody Responses During Chronic HIV-1 Infection
Hraber, Peter, Michael S. Seaman, Robert T. Bailer, John R. Mascola, David C. Montefiori, and Bette T. Korber. 2014. “Prevalence of Broadly Neutralizing Antibody Responses During Chronic HIV-1 Infection”. Aids. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/qad.0000000000000106.
New England Journal of MedicineJournal
Immune-correlates Analysis of an HIV-1 Vaccine Efficacy Trial
Haynes, Barton F., Peter B. Gilbert, M. Juliana McElrath, Susan Zolla-Pazner, Georgia D. Tomaras, S. Munir Alam, David T. Evans, et al.. 2012. “Immune-correlates Analysis of an HIV-1 Vaccine Efficacy Trial”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1113425.
clinicaltrials.govStudy
10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults
David Ho 2019. "10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03875209.
~9 spots leftby Apr 2025
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