PEP, HIV
Conditions
Interventions
none
Sponsors
University Medical Centrum Utrecht
Eligibility
Inclusion criteria
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 -No contra-indications against either DTG or RAL both with TDF / FTC or 3TC in the judgement of the prescribing physician -Start of PEP ¡Ü 72 hours before the day of study inclusion -18 years or older -Able to understand the study information and sign an informed consent -Willing and according to the investigator able to follow the study procedures
Exclusion criteria
Exclusion criteria: -pregnancy -lactation -baseline laboratory results abnormalities which fall in Grade 3 and 4 according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.0 November 2014 -not being able to adhere to study procedures according to the treating physician -unable to fill of understand the study questionnaires (provided in Dutch or English) -active hepatitis B -eGFR5 times ULN -positive HIV serology at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Grade 2 to 4 neurocognitive adverse events (according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.0, published in November 2014) -BSI questionnaire score -SF-36 questionnaire score -Insomnia severity questionnaire score | — |
Secondary
| Measure | Time frame |
|---|---|
| -Grade 2 to 4 non-neurocognitive clinical adverse events -Grade 3 to 4 laboratory adverse events Both according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.0, published in November 2014. | — |
Contacts
Public ContactB. Silvius
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Outcome results
None listed