NCT02588586

A Study of the Safety and Antiretroviral Activity of 3BNC117

An Open Label, Phase 2 Study of the Safety and Antiretroviral Activity of 3BNC117 in HIV-Infected Individuals on Combination Antiretroviral Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying rebound of viral load during a brief treatment interruption of standard ART, and its safety during a brief analytical interruption of antiretroviral therapy.

Detailed description

The proposed study is a Phase II, open label study to evaluate the safety, antiretroviral activity and pharmacokinetics of four infusions of 3BNC117 in HIV-infected individuals on combination ART and during a brief analytical treatment interruption (ATI). Study participants will be administered four intravenous infusions of 3BNC117, administered at 30 mg/kg on day 0, week 12, week 24 and week 27. Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion (week 24), until week 36. The ART regimen will be resumed at week 36 or sooner if plasma HIV-1 RNA level is ≥ 200 copies/ml, CD4+ T cell count drops \< 350 cells/microliter, and results are confirmed upon repeat measurement during the next weekly scheduled visit. If plasma HIV-1 RNA level is ≥ 1,000 copies/ml, the participant will be asked to return for a repeat measurement prior to the next scheduled visit, and ART will be resumed if results are confirmed. ART will also be resumed early if the participant becomes pregnant or if otherwise clinically indicated. If ART is resumed before week 27, the fourth 3BNC117 infusion will not be administered. Participants will be followed weekly during the analytical treatment interruption phase for safety assessments and for monitoring plasma HIV-1 RNA levels. CD4+ T cell counts will be monitored every 2 weeks during the analytical treatment interruption phase. Participants may remain off antiretroviral therapy after week 36, with weekly viral load monitoring, if viral rebound does not occur by week 36. All participants will be followed for a total of 60 weeks from enrollment.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	3BNC117	3BNC117 infusions
OTHER	Antiretroviral Treatment Interruption	Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-02-01
• Completion: 2018-04-01
• First posted: 2015-10-28
• Last updated: 2021-06-16
• Results posted: 2021-06-16

Locations

2 sites across 1 country: United States