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Clinical investigation of HIV infection diagnostic kit

Clinical investigation of HIV infection diagnostic kit - Clinical investigation of HIV infection diagnostic kit

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021201
Enrollment
200
Registered
2016-02-26
Start date
2016-03-01
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

HIV infection

Interventions

Comparison between conventional method and new test

Sponsors

Keio University School of Medicine Center for Infectious Disease and Infection Control
Lead Sponsor
Kanagawa Prefectural Institute of Public Health
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Disease group 1) Patient with HIV infection. 2) Enable to obtain the written informed consent. Healthy group 1) HIV-non infected.

Exclusion criteria

Exclusion criteria: Disease group 1) Patient who have been infected for HIV within one month. 2) Unable to have sighed informed consent. 3) Patients whose phycian consider the study enrollment inappropreate. Healthy group 1) HIV infected 2) Uncontrolled diabetes 3) Tumor-bearing 4) Taking immunosuppressive drug 5) Patients whose physician consider the study enrollment inappropreate

Design outcomes

Primary

MeasureTime frame
Concordance between new test and western-blot analysis

Secondary

MeasureTime frame
Concordance between new test and HIV-antibody test which is used for HIV infection screening

Countries

Japan

Contacts

Public ContactShingo Kato

Keio University School of Medicine Department of Microbiology and Immunology

skato@a3.keio.jp03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026