Establishment of the concept of immune reconstitution syndrome not related to HIV infection with study for development of biomarkers

Establishment of the concept of non-HIV immune reconstitution inflammatory syndrome (IRIS) with study for development of biomarkers. - Establishment of the concept of non-HIV IRIS with study for development of biomarkers.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040607

Enrollment

120

Registered

2020-06-05

Start date

2020-06-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immune reconstitution inflammatory syndrome (IRIS)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with drug-induced hypersensitivity syndrome, collagen disease / autoimmune disease before the start of immunomodulators, or patients who meet the diagnostic criteria for IRIS.

Exclusion criteria

Exclusion criteria: 1) Those who have difficulty in visiting the hospital regularly 2) Those with severe anemia and less than (hemoglobin 9.0 g / mL) 3) Those who have difficulty in collecting saliva due to dry mouth 4) Patients who are judged to be ineligible according to the judgment of the research doctor.

Design outcomes

Primary

Measure	Time frame
By comparing the group that developed the IRIS event with the group that did not develop the disease, a diagnostic biomarker with high sensitivity and specificity and an onset prediction biomarker are extracted from among cytokine / chemokine / hemocyte markers and viral amount.	—

Secondary

Measure	Time frame
Neutrophil / lymphocyte ratio at the start of treatment of the primary disease and at the onset of IRIS event	—

Countries

Japan

Contacts

Public ContactSachiko Koshikawa

Showa University Department of Dermatology

skoshi@cnt.showa-u.ac.jp03-3784-8556

Outcome results