Albuvirtide for Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Infections+1 More
Albuvirtide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new long-acting HIV treatment that could help people stay virally suppressed.

Eligible Conditions
  • Infections
  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 16 weeks in Part 1 and part 2, 28 weeks in part 3

Week 16
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 1 of the study
Week 28
Emergence of new resistance mutations to antiretroviral drugs as evaluated by GenoSure Archive or PhenoSense GT Assay
Mean change in CD4 cell count, at each visit within the treatment phase
Mean change in CD4:CD8 ratio, at each visit within the treatment phase
Mean change in HIV-1 RNA, at each visit within the treatment phase
Measurement of treatment adherence to the ABT and 3BNC117 combination regimen
Proportion of participants achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Time to virologic rebound after discontinuation of baseline ART regimen
Week 16
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 2 of the study
Week 28
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 3 of the study.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

7 Treatment Groups

Control Arm 1: Baseline ART
1 of 7
Control Arm 2: Baseline ART
1 of 7
Cohort 3: albuvirtide & 3BNC117
1 of 7
Optimal Dose: albuvirtide & 3BNC117
1 of 7
Cohort 4: albuvirtide & 3BNC117
1 of 7
Cohort 1: albuvirtide & 3BNC117
1 of 7
Cohort 2: albuvirtide & 3BNC117
1 of 7

Active Control

Experimental Treatment

80 Total Participants · 7 Treatment Groups

Primary Treatment: Albuvirtide · No Placebo Group · Phase 2

Cohort 3: albuvirtide & 3BNC117Experimental Group · 2 Interventions: Albuvirtide, 3BNC117 · Intervention Types: Drug, Drug
Optimal Dose: albuvirtide & 3BNC117Experimental Group · 2 Interventions: Albuvirtide, 3BNC117 · Intervention Types: Drug, Drug
Cohort 4: albuvirtide & 3BNC117Experimental Group · 2 Interventions: Albuvirtide, 3BNC117 · Intervention Types: Drug, Drug
Cohort 1: albuvirtide & 3BNC117Experimental Group · 2 Interventions: Albuvirtide, 3BNC117 · Intervention Types: Drug, Drug
Cohort 2: albuvirtide & 3BNC117Experimental Group · 2 Interventions: Albuvirtide, 3BNC117 · Intervention Types: Drug, Drug
Control Arm 1: Baseline ART
Drug
ActiveComparator Group · 1 Intervention: Baseline ART · Intervention Types: Drug
Control Arm 2: Baseline ART
Drug
ActiveComparator Group · 1 Intervention: Baseline ART · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3BNC117
2017
Completed Phase 2
~170

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks in part 1 and part 2, 28 weeks in part 3

Who is running the clinical trial?

Frontier Biotechnologies Inc.Lead Sponsor
11 Previous Clinical Trials
2,080 Total Patients Enrolled
3 Trials studying Infections
132 Patients Enrolled for Infections
Frontier clinical teamStudy DirectorFrontier Biotechnologies Inc.
1 Previous Clinical Trials
34 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The antiretroviral regimen (the medicines a person takes to treat HIV) has not changed in the last 4 weeks prior to the Screening Visit and between the Screening Visit and the First Treatment Visit, with the exception that people who are taking an NNRTI-containing regimen (a type of antiretroviral therapy) will be allowed to switch to a protease inhibitor- or integrase strand transferase inhibitor-based regimen, and the change should happen at least 4 weeks before stopping oral antiretroviral therapy.
The subject has not had a documented detectable viral load (HIV-1 RNA > 50 copies/mL) within the last 24 weeks prior to the Screening Visit
The patient's plasma HIV-1 RNA was below 50 copies/mL at the screening visit as determined by a HIV-1 quantitative, RNA test.
Screening Visit occurred within the past 6 months The subject has a CD4 cell count of over 300 cells/mm3 and the screening visit happened within the past 6 months.
Having received oral combination antiretroviral therapy for the last 24 weeks.
Potential subjects for enrollment in the study must meet all of the following criteria.
clinician and patient weigh treatment options A person who is HIV-positive may have two or more potential alternative antiretroviral drug options available
A patient has an absolute neutrophil count (ANC) of ≥750/mm3 if their neutrophil count is ≥750 cells/mm3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.