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Broadly Neutralizing Antibodies 3BNC117-LS & 10-1074-LS to Prevent Relapse During ATI

NCT05079451 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-09-07

No results posted yet for this study

Summary

Participants will receive an infusion of both study drugs (3BNC117-LS and 10-1074-LS) and will discontinue antiretroviral therapy (which is the treatment for HIV) two days later. Participants will receive a second dose of the first study drug (3BNC117-LS) at week 12 if the HIV infection is maintained and participants remain off of antiretroviral therapy. The study hypothesizes that intravenous infusions (which means medication is delivered directly into a participant's vein) of the combination of study drugs will be safe and well tolerated, will maintain control of the HIV infection without antiretroviral therapy, and may be associated with a decrease in HIV found in cells that were previously infected with HIV but not actively producing HIV in the body.

Conditions

  • HIV Infections

Interventions

DRUG

3BNC117-LS

3BNC117-LS will be administered by intravenous infusion (directly into the participants vein) over a period of 30 to 60 minutes. The total time needed to administer the study drug may be longer, based on factors such as participant tolerance. The participant's dose will be calculated using their most current weight on record.

DRUG

10-1074-LS

10-1074-LS will be administered by intravenous infusion (directly into the participants vein) over a period of 30 to 60 minutes. The total time needed to administer the study drug may be longer, based on factors such as participant tolerance. The participant's dose will be calculated using their most current weight on record.

Sponsors & Collaborators

  • Rockefeller University

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Katharine J Bar, M.D. · University of Pennsylvania

  • Marina Caskey, M.D. · The Rockefeller University Non-Network CRS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-01-15
Completion
2024-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05079451 on ClinicalTrials.gov