Status:
COMPLETED
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
Lead Sponsor:
Janssen-Cilag G.m.b.H
Conditions:
Human Immunodeficiency Virus (HIV)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to assess the rate of early discontinuation from randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason other than confirmatio...
Detailed Description
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 effe...
Eligibility Criteria
Inclusion
- Occupational injury and non-occupational exposure with documented human immunodeficiency virus (HIV) exposure, or potential for HIV exposure
- Indication for HIV postexposure prophylaxis (PEP), as determined by the treating physician and/or the investigator
- Women must be: postmenopausal (for at least 2 years), surgically sterile, using oral contraceptives
- Willing to continue HIV PEP for 28 days
Exclusion
- Positive HIV rapid test
- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastro intestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Pregnant or breast-feeding
- Any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
Key Trial Info
Start Date :
November 25 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2013
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT01516970
Start Date
November 25 2011
End Date
September 28 2013
Last Update
July 19 2017
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Berlin, Germany
2
Bonn, Germany
3
Cologne, Germany
4
Dortmund, Germany