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Albuvirtide for HIV (ABL Trial)
Phase 2
Waitlist Available
Research Sponsored by Frontier Biotechnologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks in part 1 and part 2, 28 weeks in part 3
Awards & highlights
ABL Trial Summary
This trial is testing a new long-acting HIV treatment that could help people stay virally suppressed.
Eligible Conditions
- HIV
ABL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks in part 1 and part 2, 28 weeks in part 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks in part 1 and part 2, 28 weeks in part 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 3 of the study.
Secondary outcome measures
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
+7 moreABL Trial Design
7Treatment groups
Experimental Treatment
Active Control
Group I: Optimal Dose: albuvirtide & 3BNC117Experimental Treatment2 Interventions
albuvirtide and 3BNC117 every 2 or 4 weeks
Group II: Cohort 4: albuvirtide & 3BNC117Experimental Treatment2 Interventions
albuvirtide 0.16 g and 3BNC117 0.8 g every 4 weeks
Group III: Cohort 3: albuvirtide & 3BNC117Experimental Treatment2 Interventions
albuvirtide 0.32 g and 3BNC117 0.8 g every 4 weeks
Group IV: Cohort 2: albuvirtide & 3BNC117Experimental Treatment2 Interventions
albuvirtide 0.32 g and 3BNC117 2 g every 4 weeks
Group V: Cohort 1: albuvirtide & 3BNC117Experimental Treatment2 Interventions
albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks
Group VI: Control Arm 1: Baseline ARTActive Control1 Intervention
Subjects continuing on baseline ART
Group VII: Control Arm 2: Baseline ARTActive Control1 Intervention
Subjects continuing on baseline ART
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Albuvirtide
Not yet FDA approved
3BNC117
2017
Completed Phase 2
~170
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Who is running the clinical trial?
Frontier Biotechnologies Inc.Lead Sponsor
12 Previous Clinical Trials
3,416 Total Patients Enrolled
Frontier clinical teamStudy DirectorFrontier Biotechnologies Inc.
1 Previous Clinical Trials
34 Total Patients Enrolled
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