NCT04250636

3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals

An Open Label, Single Arm Study of the Safety, Pharmacokinetics and Antiretroviral Activity of the Combination of 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is a phase 1, open label, single arm study to evaluate the safety, pharmacokinetics and antiviral activity of single intravenous infusions of 3BNC117-LS and 10-1074-LS, each monoclonal antibody (mAb) dosed at 30 mg/kg in viremic human immunodeficiency virus (HIV)-infected individuals.

Detailed description

The proposed study is a phase 1, open label, single arm study to evaluate the safety, pharmacokinetics and antiviral activity of single intravenous infusions of 3BNC117-LS and 10-1074-LS in viremic HIV-infected individuals. Ten eligible participants will be enrolled sequentially in the study and will receive each mAb, dosed at 30 mg/kg intravenously and in sequence on study day 0. Following mAb administration, study participants will return for safety assessments on days 1 and 3, and weeks 1, 2, 3 and 4 following dosing, then bi-weekly or monthly until the end of study follow up. All participants will be followed for 24 weeks after 3BNC117-LS and 10-1074-LS administration. Safety assessments will be performed at multiple time points following 3BNC117-LS and 10-1074-LS infusions. Serum samples for pharmacokinetic (PK) measurements will be collected before and at the end each mAb infusion administration and at multiple subsequent time points during study follow up. Samples will also be collected for measurement of HIV-1 plasma RNA levels before 3BNC117-LS and 10-1074-LS infusions (screen and day 0) and at every follow up visit. T cell subsets will also be monitored during study follow up. Assessments will also include measurement of anti-drug antibody responses and sequencing of plasma envelope before infusions and after viral rebound (first time point after viremia nadir is reached and viral load (VL) is \> 1,000 copies/ml). Participants will be advised and encouraged to start antiretroviral therapy (ART) within 4 weeks of receiving 3BNC117-LS and 10-1074-LS infusions or sooner if: VL fails to decrease by \> 0.5 log10 copies/ml within 2 weeks of antibody infusions, VL increases \> 0.5 log10 copies/ml between weekly measurements or significant T-cell decline (confirmed CD4+ T cells \< 200 cells/μl) is noted.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	3BNC117-LS	Intravenous infusion of 3BNC117-LS at 30mg/kg
DRUG	10-1074-LS	Intravenous infusion of 10-1074-LS at 30mg/kg

Timeline

• Start date: 2020-10-13
• Primary completion: 2022-01-21
• Completion: 2022-02-11
• First posted: 2020-01-31
• Last updated: 2023-06-26
• Results posted: 2023-06-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study