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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 40 and 80

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to end of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Solicited and unsolicited grade 3 or higher adverse events
Secondary study objectives
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
3,336 Previous Clinical Trials
5,392,564 Total Patients Enrolled
Michael C Sneller, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
10 Previous Clinical Trials
5,389 Total Patients Enrolled

Media Library

10-1074-LS (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05612178 — Phase 1
HIV Research Study Groups: Placebo, 3BNC117-LS and 10-1074-LS
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
~76 spots leftby Dec 2025
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