Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03719664
Study type Interventional
Source Frontier Biotechnologies Inc.
Contact Jing Bao, M.D.
Phone (+86) 025 69760339
Email jbao@frontierbiotech.com
Status Not yet recruiting
Phase Phase 2
Start date November 2018
Completion date October 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03227731 - Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women Phase 2/Phase 3
Recruiting NCT03416790 - IMPAACT 2015 - Evaluation of the HIV-1 Reservoir in the Central Nervous System of Perinatally-Infected Youth and Young Adults With Cognitive Impairment
Recruiting NCT03570918 - MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy Phase 1
Not yet recruiting NCT03624413 - InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media N/A
Recruiting NCT03536234 - Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients Phase 2
Not yet recruiting NCT03549689 - Effect of Reducing Nucleotide Exposure on Bone Health (ReNew) Phase 2
Not yet recruiting NCT03705169 - Pharmacokinetics of SAR441236 Phase 1
Active, not recruiting NCT03251690 - Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression N/A
Recruiting NCT03532425 - B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults Phase 4
Not yet recruiting NCT03709355 - Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs Phase 1
Not yet recruiting NCT03580668 - Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide
Not yet recruiting NCT03199690 - A Clinical Study Investigating Rifampicin and Dolutegravir in Combination in Healthy Volunteers Phase 1
Active, not recruiting NCT01466582 - Comorbidity and Aging With HIV N/A
Recruiting NCT03148964 - Primary Infection Cohort N/A
Recruiting NCT03512210 - Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection Phase 4
Recruiting NCT03706898 - Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs Phase 1
Active, not recruiting NCT03312244 - Pyridostigmine as Immunomodulator in People Living With HIV Phase 2
Withdrawn NCT03074786 - Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH) Phase 2
Recruiting NCT03539224 - Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept. Phase 2
Completed NCT03226873 - Peer Outreach and Navigation Intervention to Increase PrEP Uptake Among Women at High Risk for HIV N/A