Peg-Interferon Alpha 2b Combined With Two Intravenous Broadly HIV-1 Neutralizing Antibodies 3BNC117 and 10-1074 (BEAT-2)

• Status: Active, not recruiting
• Trial end date: 2022-10-30

Summary

This study will evaluate the safety, tolerability and innate immune mechanisms activation following administration of the combination of Pegylated Interferon alpha 2b (peg-IFN-α2b) with two broadly neutralizing antibodies (3BNC117 and 10-1074) in the setting of well-controlled HIV infection with antiretroviral treatment and a monitored analytical treatment interruption. The current proposal builds on previous experience using interferon alpha, 3BNC117 and 10-1074 alone in separate clinical trials that included a closely monitored analytical treatment interruption. The hypothesis is that the joint administration of peg-IFN-α2b with 3BNC117 and 10-1074 will be more effective than either intervention separately in suppressing HIV viremia during 8 weeks of analytical treatment interruption (Step 4) and reducing integrated HIV DNA in blood and tissue when measured during an analytical treatment interruption in patients with well-controlled HIV infection.

• Phase: Phase 1

Details

• Lead Sponsor: Luis Montaner
• Collaborators: Merck Sharp & Dohme Corp.; National Institute of Allergy and Infectious Diseases (NIAID); Philadelphia Fight; Rockefeller University; University of Pennsylvania
• Treatments: Antibodies; Antibodies, Blocking; Immunoglobulins; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b