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Monoclonal Antibodies

Canakinumab for HIV/AIDS

Phase 2
Waitlist Available
Research Sponsored by Priscilla Hsue, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8, 12, 18, 24, and 36.
Awards & highlights

Study Summary

This trial will study the effects of canakinumab, a drug that inhibits IL-1β, on indicators of cardiovascular risk in people with HIV who have suppressed the virus.

Eligible Conditions
  • HIV/AIDS
  • Cardiovascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12, 18, 24, and 36.
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, 12, 18, 24, and 36. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ALT From Baseline to Follow-up
Change in AST From Baseline to Follow-up
Change in Absolute Neutrophil Count From Baseline to Follow-up
+4 more
Secondary outcome measures
Arterial Inflammation Measured at Baseline and Follow-up at Week 12
D-Dimer
Flow-Mediated Dilation (FMD)
+2 more

Side effects data

From 2017 Phase 3 trial • 203 Patients • NCT02059291
50%
Bronchitis
50%
Diarrhoea
50%
Conjunctivitis
50%
Gastroenteritis
50%
Drug eruption
25%
Pyoderma gangrenosum
25%
Teething
25%
Pyogenic granuloma
25%
Dental caries
25%
Eye allergy
25%
Gastritis
25%
Nausea
25%
Vomiting
25%
Nasopharyngitis
25%
Malaise
25%
Aspartate aminotransferase increased
25%
Tonsillitis bacterial
25%
Alanine aminotransferase increased
25%
Neutrophil count increased
25%
Pain in extremity
25%
Headache
25%
Dermatitis allergic
25%
Rash pruritic
25%
Scleritis
25%
Hyper IgD syndrome
25%
Eye pain
25%
Familial mediterranean fever
25%
Constipation
25%
Stomatitis
25%
Influenza
25%
Rhinitis
25%
Sialoadenitis
25%
Viral upper respiratory tract infection
25%
C-reactive protein increased
25%
Neutrophil count decreased
25%
Serum amyloid A protein increased
25%
White blood cell count increased
25%
Hypocalcaemia
25%
Arthralgia
25%
Back pain
25%
Somnolence
25%
Eczema
25%
Keloid scar
25%
Urticaria
25%
Aphthous ulcer
25%
Ear infection
25%
Hypophosphataemia
25%
Pancytopenia
25%
Hepatic failure
25%
Laryngitis
25%
Haemorrhoids
25%
Pyrexia
25%
Viral tonsillitis
25%
Dehydration
25%
Pain of skin
25%
Skin ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-randomized Open Label crFMF, HIDS/MKD Patients
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - ACZ Events
Any ACZ crFMF Patients - ACZ Events
Randomized ACZ and Placebo crFMF Pts - No Medication Events
Non-randomized Open Label TRAPS Patients
Any ACZ crFMF Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Pts - No Medication Events
Any ACZ HIDS/MKD Patients - No Medication Events
Any ACZ HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
Any ACZ TRAPS Patients - Placebo Events
Any ACZ TRAPS Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - Placebo Events
Any ACZ TRAPS Patients - no Medication Events
Any ACZ HIDS/MKD Patients - Placebo Events
Any ACZ crFMF Patients - No Medication Events

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Safety ArmExperimental Treatment1 Intervention
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Group II: CanakinumabExperimental Treatment1 Intervention
In Stage II: About 67 subjects will receive 150mg Canakinumab subcutaneous injection.
Group III: PlaceboPlacebo Group1 Intervention
In Stage II: About 33 subjects will receive 150mg placebo subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3090

Find a Location

Who is running the clinical trial?

Priscilla Hsue, MDLead Sponsor
3 Previous Clinical Trials
155 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,929 Previous Clinical Trials
13,198,262 Total Patients Enrolled

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
Current Opinion in HIV and AIDSJournal
Cardiovascular Disease Risk in Women Living with HIV
Kentoffio, Katherine, Tecla M. Temu, Saate S. Shakil, Markella V. Zanni, and Chris T. Longenecker. 2022. “Cardiovascular Disease Risk in Women Living with HIV”. Current Opinion in HIV and AIDS. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/coh.0000000000000756.
Current Opinion in HIV and AIDSJournal
Cardiovascular Disease Risk in Women Living with HIV
Kentoffio, Katherine, Tecla M. Temu, Saate S. Shakil, Markella V. Zanni, and Chris T. Longenecker. 2022. “Cardiovascular Disease Risk in Women Living with HIV”. Current Opinion in HIV and AIDS. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/coh.0000000000000756.
clinicaltrials.govStudy
Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk
Priscilla Hsue, MD 2015. "Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02272946.
~4 spots leftby Apr 2025
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