NCT02825797

3BNC117 and 10-1074 in HIV-infected Individuals

An Phase 1b Study of the Safety, Pharmacokinetics and Antiretroviral Activity of the Combination of 3BNC117 and 10-1074 in HIV-infected Individuals

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the combination of two anti-human immunodeficiency virus (HIV) broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in HIV-infected individuals. This study is intended to support the development of the combination of 3BNC117 and 10-1074 mAbs for use in the treatment of HIV-1 infection.

Detailed description

The proposed study is a Phase 1b clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the combination of two anti-HIV broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in HIV-infected individuals. The study includes 5 study groups. Study participants will be administered one or three intravenous infusions of 3BNC117 and 10-1074, each mAb dosed at 10 or 30 mg/kg: Single dose groups: Group 1A (n=6) - HIV-infected individuals, on antiretroviral therapy (ART) with HIV-1 RNA \< 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one infusion of 10-1074, each dosed at 10 mg/kg (n=4), OR placebo (sterile saline; n=2), on day 0. Group 1B (n=6) - HIV-infected individuals, on ART with HIV-1 RNA \< 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one infusion 10-1074, each dosed at 30 mg/kg (n=4), OR placebo (sterile saline; n=2), on day 0. Participants and investigators will be blinded to study assignment in groups 1A and 1B. Group 1C (n=4) - HIV-infected individuals, off ART will be administered one infusion of 3BNC117 and one infusion 10-1074, each dosed at 30 mg/kg, on day 0. Three doses groups: Group 2 (n=15) - HIV-infected individuals, on ART who will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg, on days 0, 21 (week 3) and 42 (week 6). Participants enrolled in Group 2 will discontinue their antiretroviral (ART) regimen on day 2. Group 3 (n=6) - HIV-infected individuals, off ART who will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg on days 0, 14 (week 2) and 28 (week 4). Following 3BNC117 and 10-1074 infusions, study participants will return for safety assessments at multiple time points. Blood samples will be collected for safety testing at weeks 1, 2, and 4 following each mAb infusion, then bi-monthly or monthly until the end of study follow up. Serum samples for PK (pharmacokinetic) measurements will be collected before the start of the first mAb infusion. Peak PK sampling for 3BNC117 will occur following the completion of the 3BNC117 infusion and prior to the start of the 10-1074 infusion. Peak PK sampling for 10-1074 will occur following the completion of the 10-1074 infusion. Additional samples for PK assessments will be collected at multiple time points during study follow up. Samples will also be collected for measurement of HIV-1 plasma RNA levels before 3BNC117 and 10-1074 infusions (screen, pre-infusion and day 0), at all follow up visits in Groups 1A, 1B and 2, and weekly during the ATI period and at later time points in Group 2. All participants will be followed for 24 weeks after the last 3BNC117 and 10-1074 infusions.

Conditions

• Human Immunodeficiency Virus (HIV)

Interventions

Type	Name	Description
DRUG	3BNC117	Intravenous infusion of 3BNC117
DRUG	10-1074	Intravenous infusion of 10-1074
OTHER	Analytical treatment interruption	Analytical treatment interruption
DRUG	Placebo	Intravenous infusion of placebo (sterile saline)

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-08-01
• Completion: 2018-08-15
• First posted: 2016-07-07
• Last updated: 2018-08-21

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study