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Monoclonal Antibodies

3BNC117-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
Documented HIV-1 infection.
Ability and willingness of participant to provide informed consent to enter the Screening and Pre-Entry segment of the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights

Study Summary

This trial is testing whether a combination of two drugs can keep HIV under control without the use of antiretroviral therapy. If the HIV infection is maintained, participants will receive a second dose of the first study drug. The study hypothesizes that the combination of study drugs will be safe and well tolerated and may be associated with a decrease in HIV found in cells that were previously infected with HIV.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 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
Occurrence of Grade ≥3 systemic AE related to combination of 3BNC117-LS and 10-1074-LS or premature study treatment discontinuation due to an AE (regardless of grade) that is related to combination of 3BNC117-LS and 10-1074-LS.
Viral rebound defined as confirmed HIV-1 RNA >200 copies/mL at or prior to week 24 of ART discontinuation.
Secondary outcome measures
Actual body exposure to drug after administration of a dose of the drug (known as the "Area under the curve (AUC)") of weeks 0-24 for 3BNC117-LS and 10-1074-LS.
Actual body exposure to drug after administration of a dose of the drug (known as the "Area under the curve (AUC)") of weeks 0-infinity for 3BNC117-LS and 10-1074-LS.
CD4+ cell counts (cells/mm3) through entire study follow-up.
+6 more

Side effects data

From 2022 Phase 1 trial • 6 Patients • NCT04250636
17%
Pyrosis
17%
Penile trauma
17%
Tinea capitis
17%
Seasonal allergy
17%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study Participants

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study ParticipantsExperimental Treatment2 Interventions
Participants will receive an infusion of both study drugs (3BNC117-LS and 10-1074-LS) and will then discontinue antiretroviral therapy two days later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3BNC117-LS
2020
Completed Phase 1
~130
10-1074-LS
2020
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,132 Total Patients Enrolled
Rockefeller UniversityOTHER
158 Previous Clinical Trials
16,357 Total Patients Enrolled
Katharine J Bar, M.D.Study ChairUniversity of Pennsylvania

Frequently Asked Questions

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

Which individuals meet the requirements for participating in this research?

"This medical trial is recruiting 30 humans infected with HIV aged between 18 and 70. The following requirements must be fulfilled for eligibility: Capacity to grant informed consent for participation in the screening and pre-entry stages of this research; age ranging from 18 to 70 years old; bodyweight no less than 50 kg (110 lbs) nor more than 115 kg (253.5lbs); positive diagnosis of Human Immunodeficiency Virus Type 1; negative pregnancy test at Screening if applicable; two contraceptive methods during study period if applicable, along with use of barrier protection when engaging in any sexual activity that could lead to conception."

Answered by AI

Is the current clinical trial accepting participants of advanced age?

"According to the parameters of this trial, participants must be at least 18 years old and not more than 70."

Answered by AI

Is 3BNC117-LS deemed to be a safe treatment for individuals?

"Our team at Power assigned 3BNC117-LS a score of 1 on the safety scale, due to its Phase 1 classification indicating limited preclinical data in terms of both efficacy and safety."

Answered by AI

Are there any vacancies for individuals to join this research endeavor?

"Unfortunately, this clinical trial is not accepting applicants at the moment. Initially posted on November 30th 2021 and lastly updated two weeks later, there are 485 other medical studies recruiting patients."

Answered by AI

In how many sites is this research project being managed?

"Northwestern University CRS in Chicago, UCSD Antiviral Research Center CRS in San Diego, and UCLA CARE Center CRS in Los Angeles are amongst the five clinical sites that have been enlisted for this project. Additionally, two other locations have also been included for participation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Broadly Neutralizing Antibodies 3BNC117-LS & 10-1074-LS to Prevent Relapse During ATI
2024. "Broadly Neutralizing Antibodies 3BNC117-LS & 10-1074-LS to Prevent Relapse During ATI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05079451.
~0 spots leftby Apr 2025
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