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NCT05551273 · ClinicalTrials.gov registry record · Phase 2
Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
A Phase 2 study of HIV Infections and Hepatitis B, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 20
- Study locations
NCT05551273: Active Phase 2 study of HIV Infections and Hepatitis B, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05551273 is a Phase 2 study of HIV Infections and Hepatitis B that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 29 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05551273, a Phase 2 study of HIV Infections and Hepatitis B, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Selgantolimod
Study Locations (20)
Other
- Hospital Nossa Senhora da Conceicao CRS - Porto Alegre
- Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS Site ID# 12101 - Rio de Janeiro
- Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS - Rio de Janeiro
- GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS - Port-au-Prince
New York
- Weill Cornell Chelsea CRS - New York
- Columbia P&S CRS - New York
- Weill Cornell Uptown CRS - New York
Ohio
- Cincinnati Children's Hosp / Univ Hosp - Cincinnati
- Case CRS Site ID# 2501 - Cleveland
- Ohio State University CRS - Columbus
North Carolina
- Chapel Hill CRS - Chapel Hill
- Greensboro CRS Site# 3203 - Greensboro
Alabama
- Alabama CRS - Birmingham
California
- UCSD Antiviral Research Center CRS - San Diego
Georgia
- The Ponce de Leon Center CRS - Atlanta
Illinois
- Northwestern University CRS - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2023-05-05 |
| Est. Completion | 2026-04-29 |
| Phase | Phase 2 |
What the registry record for NCT05551273 still lists
NCT05551273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05551273 names 20 study sites across 12 states, led by Other, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT05551273 about?
NCT05551273 is a clinical study titled "Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV". 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) ...
What is the current status of trial NCT05551273?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2023-05-05. Estimated completion is 2026-04-29.
What conditions does trial NCT05551273 study?
This clinical trial studies the following conditions: HIV Infections, Hepatitis B.
What interventions are being tested in trial NCT05551273?
The interventions under investigation include: Placebo (DRUG), Selgantolimod (DRUG).
Who is sponsoring clinical trial NCT05551273?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05551273 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05551273's enrollment target sits among peer trials
29 442nd of 542 higher than 97 of 542 other HIV Infections trials
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