NCT04819347

Albuvirtide in Combination With 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection

The Phase 2, Two Arms, One Site, Safety and Antiviral Activity of Combination Therapy With Albuvirtide and 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection After Analytical Treatment Interruption

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study to evaluate the safety and tolerability of combination therapy with Albuvirtide (ABT) and 3BNC117 in virologically suppressed subjects with HIV-1 infection and explore the potential of viral suppression and viral reservoir clearance after analytical treatment interruption (ATI).

Detailed description

This is an open-label, one site study, in which a total of 24 HIV-1 subjects who are virologically suppressed and stable on daily oral combination antiretroviral therapy will be enrolled. All eligible patients will be switched from daily oral combination antiretroviral regimen to treatment of ABT and 3BNC117 for 14 weeks. There is a two-week overlap of the baseline oral antiretroviral therapy and the ABT-3BNC117 combination regimen at the beginning of the study treatment, and then the oral ART will be interrupted. The patients will be monitored for viral rebound every two or four weeks following initiation of ABT-3BNC117 combination and will re-initiate an oral antiretroviral regimen if virological rebound is confirmed with plasma HIV-1 RNA levels above 200 copies/ml on two consecutive test. Pharmacokinetics of ABT and 3BNC117 will be assessed in this study.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
DRUG	Albuvirtide	Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
DRUG	3BNC117	Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120.

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2021-03-26
• Last updated: 2021-03-26

Locations

1 site across 1 country: China