drugset / Trial / NCT01440569

Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

NCT01440569

NaSingle-groupOpen-labelTreatment

Summary

This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.

Timeline

Start
2011-09
Primary completion
2012-08
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Abacavir Other / unclassified
Subject COBI Unknown 150 mg Oral
Subject DRV Unknown 800 mg Oral
Subject Didanosine Small molecule
Subject Lamivudine Other / unclassified
Subject Tenofovir disoproxil fumarate Small molecule
Subject Zidovudine Small molecule
Subject emtricitabine Other / unclassified

Indications