Arm A for HIV Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cincinnati Children's Hosp / Univ Hosp, Cincinnati, OH
HIV Infections+4 More
Selgantolimod - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The study aims to assess safety and tolerability of oral toll-like receptor (TLR) 8 agonist Selgantolimod (SLGN) administered for 24 weeks in participants with both CHB and HIV who have been receiving suppressive antiviral therapy for both viruses for ≥5 years and have qHBsAg level >1000 (3 log10) IU/mL at screening. The study will also evaluate if TLR8 stimulation with SLGN will reduce hepatitis B surface antigen (HBsAg) titers in the blood.

Eligible Conditions

  • HIV Infections
  • Hepatitis B

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: At week 4, 12, 24, 36 and 48

Week 2
Detection of plasma HIV RNA >50 copies/mL at weeks 2, 4, 24, and 48
Detection of serum HBV DNA >50 IU/mL at weeks 2, 4, 24, and 48
At week 24
Proportion of participants with ≥0.5 log10 IU/mL decline from baseline in qHBsAg after SLGN treatment at Week 24
Proportion of participants with ≥1 log10 IU/mL decline from baseline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24
Week 4
Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48
Baseline though week 48
Proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study
Proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study
Proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study
Proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up
Proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg from baseline at any time during the study after SLGN treatment initiation
Proportion of participants with ≥1 log10 IU/mL decline from baseline in qHBsAg at any time during the study after SLGN treatment Initiation
Week 24
Proportion of participants who experienced adverse events (AEs)
Proportion of participants who prematurely discontinued treatment due to adverse events (AEs)

Trial Safety

Safety Progress

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

Side Effects for

Selgantolimod 1.5 mg: HBeAg-negative CHB Participants
40%Upper respiratory tract infection
40%Nausea
30%Diarrhoea
30%Headache
20%Contusion
20%Dizziness
20%Myalgia
20%Cough
20%Fatigue
20%Pruritus
10%Epistaxis
10%Viral upper respiratory tract infection
10%Skin mass
10%Conjunctivitis allergic
10%Sinusitis
10%Citrate toxicity
10%Muscle strain
10%Urine output increased
10%Vomiting
10%Chest pain
10%Meibomian gland dysfunction
10%Atrial fibrillation
10%Constipation
10%Amenorrhoea
10%Rash
10%Exercise tolerance decreased
10%Iridocyclitis
10%Chills
10%Vision blurred
10%Neuropathy peripheral
10%Gastrooesophageal reflux disease
10%Catheter site bruise
10%Irritability
10%Rash pruritic
10%Haematoma
10%Throat irritation
10%Hypokalaemia
0%Pain in jaw
0%Nasal congestion
0%Musculoskeletal pain
0%Hypoaesthesia
0%Lower respiratory tract congestion
0%Gout
0%Taste disorder
0%Dyspnoea
0%Oropharyngeal pain
0%Herpes zoster
0%Lower respiratory tract infection
0%Medical device site dermatitis
0%Cellulitis
0%Thirst
0%Peripheral swelling
0%Laryngitis
0%Ligament sprain
0%Abdominal discomfort
0%Perineal abscess
0%Dry eye
0%Eyelids pruritus
0%Optic disc disorder
0%Tinnitus
0%Feeling hot
0%Cataract nuclear
0%Abdominal pain
0%Skin laceration
0%Muscle fatigue
0%Borderline glaucoma
0%Abdominal distension
0%Limb discomfort
0%Dizziness postural
0%Pinguecula
0%Hypomania
0%Umbilical hernia
0%Insomnia
0%Dysmenorrhoea
0%Pelvic pain
0%Menorrhagia
0%Vitreous detachment
0%Photophobia
0%Malaise
0%Abdominal pain upper
0%Abdominal pain lower
0%Palpitations
0%Lethargy
0%Libido decreased
0%Asthenia
0%Nocturia
0%Upper-airway cough syndrome
0%Productive cough
0%Arthralgia
0%Flank pain
0%Back pain
0%Joint stiffness
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03491553) in the Selgantolimod 1.5 mg: HBeAg-negative CHB Participants ARM group. Side effects include: Upper respiratory tract infection with 40%, Nausea with 40%, Diarrhoea with 30%, Headache with 30%, Contusion with 20%.

Trial Design

2 Treatment Groups

Arm A
1 of 2
Arm B
1 of 2
Experimental Treatment
Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: Arm A · Has Placebo Group · Phase 2

Arm A
Drug
Experimental Group · 1 Intervention: Selgantolimod · Intervention Types: Drug
Arm B
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selgantolimod
2018
Completed Phase 2
~120

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at week 4, 12, 24, 36 and 48
Closest Location: Cincinnati Children's Hosp / Univ Hosp · Cincinnati, OH
Photo of Cincinnati  1Photo of Cincinnati  2Photo of Cincinnati  3
N/AFirst Recorded Clinical Trial
4 TrialsResearching HIV Infections
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Treatment must include a combination of tenofovir disoproxil fumarate, lamivudine, and/or emtricitabine for at least 5 years prior to study entry.
You have HIV-1 RNA <50 copies/mL measured on at least two occasions at least 12 weeks apart, with no documented value >200 copies/mL, over the 12 months prior to study entry.
You have positive or negative HBeAg.
You are HCV antibody negative, or if the participant is HCV antibody positive, an undetectable HCV RNA.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.