NCT03719664

Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects

A Phase 2, Multicenter, Three-part Study to Establish the Dosage, Safety and Antiviral Activity of Combination Therapy With Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects With HIV-1 Infection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an adaptive, phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide (ABT) and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection.

Detailed description

This is a three-part, multicenter study that will enroll a total of 80 eligible, HIV-1 subjects who are virologically suppressed and stable on daily oral combination antiretroviral therapy. The study will be conducted in three parts. Part 1 and Part 2 are the dose-ranging portions of the study. In Part 1, 30 eligible subjects will be randomized in a 1:1:1 ratio to receive 16 weeks of combination treatment with albuvirtide and 3BNC117 or continue on the existing ART regimen under one of the three cohorts as follows: * Cohort 1: albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks * Cohort 2: albuvirtide 0.32 g and 3BNC117 2 g every 4 weeks * Control Arm 1: Subjects continuing on baseline ART In Part 2 of the study, 20 eligible subjects will be randomized in a 1:1 ratio to receive 16 weeks of combination treatment with albuvirtide and 3BNC117 under one of the two cohorts as follows: * Cohort 3: albuvirtide 0.32 g and 3BNC117 0.8 g every 4 weeks * Cohort 4: albuvirtide 0.16 g and 3BNC117 0.8 g every 4 weeks Part 3 of this study will enroll an additional 30 subjects in a 2:1 ratio to receive up to 28 weeks of combination treatment with optimal dose of albuvirtide and 3BNC117 or continue on the existing ART regimen as follows: * Optimal Dose: albuvirtide and 3BNC11 every 2 or 4 weeks * Control Arm 2: Subjects continuing on baseline ART All consenting patients, in Cohort 1 and 2 (Part 1) and Cohort 3 and 4 (Part 2) of the study, will be shifted from daily oral combination antiretroviral regimen to an intravenous infusion of ABT and 3BNC117. The total treatmentduration with the ABT and 3BNC117 combination regimen will be up to 16 weeks (for Part 1 and Part 2) or 28 weeks (for Part 3) with a two week overlap of the baseline oral antiretroviral regimen and the ABT-3BNC117 combination regimen at the beginning of the study treatment and at the end of the treatment phase in subjects who do not experience virologic rebound. During the two week overlap of baseline oral antiretrovirals and ABT-3BNC117 combination regimen at the beginning of the study treatment, subject will receive weekly doses of ABT and 3BNC117 as intravenous infusions. Beyond the overlap period, subjects in Cohort 1 will receive study treatments every two weeks and subjects in Cohort 2, 3, and 4 will receive study treatments every four weeks. Study participants will be monitored for viral rebound every two weeks following initiation of ABT-3BNC117 combination and will re-initiate an oral antiretroviral regimen if virologic rebound is confirmed with plasma HIV-1 RNA levels above 200 copies/ml on two consecutive blood draws. Pharmacokinetics of ABT and 3BNC117 will be assessed in this study.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Albuvirtide	Intravenous infusion of Albuvirtide
DRUG	3BNC117	Intravenous infusion of 3BNC117
DRUG	Baseline ART	Subjects continuing on baseline ART

Timeline

• Start date: 2018-12-17
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2018-10-25
• Last updated: 2021-09-29

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study