drugset / Trial / NCT01516970

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

NCT01516970

Phase 3 Completed 312 enrolled Janssen-Cilag GmbH
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-11-25
Primary completion
2013-08-01
Completion
2013-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 800 mg Oral
Comparator Efavirenz Other / unclassified 600 mg Oral
Comparator Lopinavir Other / unclassified 400 mg Oral
Background Zidovudine Small molecule 250 mg Oral
Background Lamivudine Other / unclassified
Comparator Ritonavir Other / unclassified 100 mg Oral
Background Tenofovir Small molecule
Background Zidovudine Small molecule
Background emtricitabine Other / unclassified