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Monoclonal Antibodies

3BNC117-LS + 10-1074-LS for HIV

Phase 1
Recruiting
Led By Michael C Sneller, M.D.
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
For participants who can become pregnant, must have a negative pregnancy test at screening and within 48 hours prior to day 0. Participant-reported history is acceptable as documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and vasectomy
Confirmed HIV-1 infection and clinically stable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout
Awards & highlights

Study Summary

This trial will evaluate if HIV-suppressing drugs 3BNC117-LS and 10-1074-LS are safe and reduce the number of HIV-infected blood cells in people with HIV on antiretroviral therapy.

Who is the study for?
Adults aged 18-70 with HIV on ART, having CD4+ T cell counts >300 cells/mcL and undetectable viral loads for at least 96 weeks. They must be able to consent, follow study procedures, not have significant health issues besides HIV, no hepatitis B or C infection, and agree to use effective contraception.Check my eligibility
What is being tested?
The trial tests if two drugs (3BNC117-LS and 10-1074-LS) can safely reduce the number of HIV-infected blood cells in people on ART compared to a saline placebo. Participants will receive doses through an IV three times over the course of the study with regular follow-ups.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions related to immune therapies such as infusion-related discomfort, allergic reactions or temporary changes in blood counts. Close monitoring during treatment is expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not pregnant and cannot become pregnant due to surgery or my partner's vasectomy.
Select...
I have HIV-1 and my condition is stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 40 and 80
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 40 and 80 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Solicited and unsolicited grade 3 or higher adverse events
Secondary outcome measures
Change in the intact proviral reservoir size
Body Weight Changes
Occurrence of Serious Adverse Events
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 3BNC117-LS and 10-1074-LSExperimental Treatment2 Interventions
Participants will receive three intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10-1074-LS (dosed at 10 mg/kg) at weeks 0, 20 and 40.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive three intravenous infusions of placebo (Sterile Saline) at weeks 0, 20 and 40.
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
3,264 Previous Clinical Trials
5,483,802 Total Patients Enrolled
Michael C Sneller, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
9 Previous Clinical Trials
5,595 Total Patients Enrolled

Media Library

10-1074-LS (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05612178 — Phase 1
HIV Research Study Groups: 3BNC117-LS and 10-1074-LS, Placebo
HIV Clinical Trial 2023: 10-1074-LS Highlights & Side Effects. Trial Name: NCT05612178 — Phase 1
10-1074-LS (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05612178 — Phase 1

Frequently Asked Questions

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

Who is eligible to join this research study?

"This medical trial is searching for 100 volunteers who are between 18 and 70 years old, with a positive diagnosis of HIV-1."

Answered by AI

How risky are 3BNC117-LS and 10-1074-LS treatments for patients?

"3BNC117-LS and 10-1074-LS have both been awarded a score of 1 due to the lack of data concerning their safety and efficacy, as this is only a Phase 1 trial."

Answered by AI

Does the age restriction of this research extend beyond seventy-five years?

"This clinical trial is open to any individual aged 18 or over, but no older than 70 years."

Answered by AI

Are enrollments still available for this experiment?

"Based on information sourced from clinicaltrials.gov, this medical trial is no longer seeking patients. Initially posted November 29th 2022 and last edited on the 23rd of that same month, 10 other trials remain open for enrollment at present."

Answered by AI
~133 spots leftby Dec 2025