Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) (PEPDar)

Primary Outcome Measures:

• Number of patients with early discontinuation from randomized human immunodeficiency virus postexposure prophylaxis (HIV PEP) [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  Number of patients with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in subjects receiving HIV PEP for at least 28 days and a maximum of 30 days.
  
  

Secondary Outcome Measures:

• Number of patients with Adverse Events as a Measure of tolerability and safety of HIV PEP [ Time Frame: Up to Month 3 ] [ Designated as safety issue: Yes ]
  Tolerability and safety of HIV PEP.
  
  
• Changes from baseline in Patient reported outcome questionaire [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: No ]
  Patient reported outcome (PRO) assessment of functional impairment in conjunction with HIV PEP in 3 inter-related domains (work, social life, and family life), as calculated from subject responses to the Sheehan Disability Scale (SDS) questionnaire.
  
  
• Percentage of patients who developed detectable HIV antibodies [ Time Frame: At Month 3 ] [ Designated as safety issue: No ]
  Seroconversion rate of HIV antibodies while receiving HIV PEP will be evaluated as the percentage of patients who developed detectable HIV antibodies.
  
  

This is a randomized (study medication assigned by chance), open-label (all people involved know the identity of the intervention), active-controlled (patients are assigned to either a recognized effective treatment or the study medication), parallel-group (each treatment group will be treated at the same time), multicenter study comparing DRV/r PEP (DRV/r administered with 2 NRTIs selected at the discretion of the investigator) to standard of care PEP (as per German-Austrian guidelines) in patients at risk of HIV infection due to HIV exposure through occupational injury and non-occupational exposure. This study consists of screening period, treatment period and a follow up period. HIV PEP will be administered for a total of at least 28 days and maximum of 30 days during treatment period, including any prestudy HIV PEP initiated before screening. Approximately 318 patients will be screened and enrolled to ensure that at least 131 patients are randomly assigned to receive DRV/r PEP or standard of care PEP. Safety will be evaluated during the entire study period. Data relating to a patient's functional impairment in conjunction with HIV PEP will be collected on Day 1 as baseline data, and further on Days 14 and 28 as well as at Month 3.