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

• Status: Completed
• Trial end date: 2013-09-28
• Target enrollment: 0
• Participant gender: All

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 confirmation of the negative HIV infection status of the index person in patients receiving HIV PEP for at least 28 and a maximum of 30 days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag G.m.b.H
• Treatments: Darunavir; Efavirenz; Lopinavir; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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