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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

Study Summary

This trial will test whether a combination of two drugs can reduce HIV-1 viral load in a one-week period.

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 25/eot
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 25/eot for reporting.

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 ≥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 outcome measures
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 more

Side effects data

From 2021 Phase 2 trial • 22 Patients • NCT03019640
100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Nausea
100%
Fever
100%
Platelet count decreased
100%
Anemia
100%
Neutrophil count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Hypotension
59%
Anorexia
55%
Hypophosphatemia
55%
Constipation
55%
Edema limbs
55%
Rash maculo-papular
50%
Headache
45%
Hypoalbuminemia
45%
Hypocalcemia
45%
Alanine aminotransferase increased
41%
Hypokalemia
41%
Dizziness
36%
Hyponatremia
36%
Anxiety
32%
Investigations
32%
Insomnia
32%
Vomiting
32%
Chills
32%
Cough
32%
Febrile neutropenia
32%
Hypertension
27%
Pain
27%
Alkaline phosphatase increased
27%
Aspartate aminotransferase increased
23%
Hypomagnesemia
23%
Infections and infestations
23%
Dysphagia
23%
Arthralgia
23%
Esophagitis
23%
Hiccups
18%
Dehydration
18%
Hypoxia
18%
Abdominal pain
18%
Allergic rhinitis
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hemorrhoids
14%
Infusion related reaction
14%
INR increased
14%
Immune system disorders
14%
Bloating
14%
Paresthesia
14%
Pleural effusion
14%
Dyspepsia
14%
Hypermagnesemia
14%
Rectal pain
9%
Upper respiratory infection
9%
Sore throat
9%
Blood bilirubin increased
9%
Bone pain
9%
Cholesterol high
9%
Creatinine increased
9%
Nasal congestion
9%
Papulopustular rash
9%
Arthritis
9%
Back pain
9%
Dry skin
9%
Dysgeusia
9%
Flushing
9%
General disorders and administration site conditions
9%
Hypernatremia
9%
Hyperuricemia
9%
Non-cardiac chest pain
9%
Renal and urinary disorders
9%
Skin ulceration
5%
Hypoglycemia
5%
Lymph node pain
5%
Tremor
5%
Hypothyroidism
5%
Lung infection
5%
Thromboembolic event
5%
Urinary tract pain
5%
Vascular disorders
5%
Weight gain
5%
Lymphocyte count increased
5%
Myalgia
5%
Urinary tract infection
5%
Urinary frequency
5%
Lung
5%
Eye disorders
5%
Gastroesophageal reflux disease
5%
Mucosal infection
5%
Metabolism and nutrition disorders
5%
Musculoskeletal and connective tissue disorder
5%
Peripheral motor neuropathy
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Rash acneiform
5%
Respiratory failure
5%
Acute kidney injury
5%
Ear pain
5%
Edema face
5%
Encephalopathy
5%
Endocrine disorders
5%
Atelectasis
5%
Atrial fibrillation
5%
Bladder infection
5%
Epistaxis
5%
Flatulence
5%
Gastrointestinal pain
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypercalcemia
5%
Neck pain
5%
Nervous system disorders
5%
Pain in extremity
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Skin hyperpigmentation
5%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)

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
12 Previous Clinical Trials
3,476 Total Patients Enrolled
Cheng Yao, M.D.Study DirectorFrontier Biotechnologies Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
2021. "Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04560569.
~6 spots leftby Apr 2025
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