DoRa studie
- Conditions
- PEP, HIV
- Registration Number
- NL-OMON26416
- Lead Sponsor
- niversity Medical Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Indication for start of postexposure prophylaxis with either DTG or RAL,
next to two NRTI agents which will be prescribed by the attending
physician at presentation
Exclusion Criteria
-pregnancy
-lactation
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Grade 2 to 4 neurocognitive adverse events (according to Division of<br>AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric<br>Adverse Events, version 2.0, published in November 2014)<br /><br>-BSI questionnaire score<br /><br>-SF-36 questionnaire score<br /><br>-Insomnia severity questionnaire score
- Secondary Outcome Measures
Name Time Method -Grade 2 to 4 non-neurocognitive clinical adverse events<br /><br>-Grade 3 to 4 laboratory adverse events<br /><br>Both according to Division of AIDS (DAIDS) Table for Grading the<br>Severity of Adult and Pediatric Adverse Events, version 2.0, published in<br>November 2014.