NCT04560569

Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection

A Multicenter, Two-Arm, 24-Week Study of Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.

Detailed description

This is a Phase 2, multi-center study to evaluate the efficacy, safety, and tolerability of ABT/3BNC117 combination in conjunction with an existing failing antiretroviral therapy (ART) for 1 week, and then with optimized background regimen (OBR) for 24 weeks, respectively. A total of 20 eligible subjects who demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic and/or phenotypic resistance to multiple classes of HIV drugs (3 classes or more) will be enrolled. Patients must have been treated with HAART for at least 6 months and be failing or have recently failed (i.e., in the last 8 weeks) therapy to determine baseline viral load.

Conditions

• HIV/AIDS

Interventions

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

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2020-09-23
• Last updated: 2021-09-29

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study