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Monoclonal Antibodies
3BNC117 Antibody for HIV/AIDS
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 week 25/eot
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment combining two drugs, albuvirtide and 3BNC117, for people with HIV-1 who are not responding to their current medications. The treatment aims to reduce the virus in the body by preventing it from entering cells and helping the immune system fight it. The study will evaluate how well this combination works and how safe it is for patients.
Eligible Conditions
- HIV/AIDS
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 25/eot
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 25/eot
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants with ≥0.5 log10 reduction in HIV-1 RNA viral load from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Secondary study objectives
Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
CD8-Positive T-Lymphocytes
Mean change in HIV-1 RNA levels (log10 copies/mL) during the course of Treatment Phase
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment2 Interventions
both ABT and 3BNC117 treatment bi-weekly
Group II: Group AExperimental Treatment2 Interventions
ABT weekly and 3BNC117 bi-weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Albuvirtide
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Frontier Biotechnologies Inc.Lead Sponsor
13 Previous Clinical Trials
3,516 Total Patients Enrolled
Cheng Yao, M.D.Study DirectorFrontier Biotechnologies Inc.
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