HIV:Human Immunodeficiency Virus
Conditions
Interventions
None listed
Sponsors
Tokyo Medical University Hospital
Tohoku University Tokyo University of Pharmacy and Life Sciences Sapporo Medical University Hospital National Center for Global Health and Medicine National Hospital Organization Osaka National Hospital National Hospital Organization Nagoya Medical Center Gifu University Hospital Chiba University Hospital Hiroshima University Hospital Ehime University Hospital Sendai Medical Center National Hospital Organization Kyushu Medical Center Japanese Network of People living with HIV/AIDS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 20 years old or older 2. diagnosed with HIV infection 3. ART untreated and starting ART for the first time
Exclusion criteria
Exclusion criteria: 1. Does not have a smartphone or tablet that can be used with ePRO 2. Severe mental illness 3. Cognitive impairment that may affect the completion of the questionnaire 4. Native language is not Japanese
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the incidence of symptom-related adverse events early in the course of antiretroviral therapy (ART) treatment (up to 3 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in adverse events early in the course of treatment (up to 3 months) 2. the worst adverse event and its rate in the early phase (up to 3 months) of treatment 3. time to occurrence of certain Grade 2 and 3 or higher adverse events early in treatment (up to 3 months) 4. differences in DCS categories and regimens between groups at 1 and 3 5. comparison of CTCAEs and PRO-CTCAEs (with and without baseline subtraction) at Visit 4 6. differences in DRS between DCS categories 7. internal consistency and construct validity of the HIVTSQ (confirmatory factor analysis) | — |
Countries
Japan
Contacts
Public ContactYusuke Sekine
Tokyo Medical University Hospital Department of Pharmacy
Outcome results
None listed