drugset / Trial / NCT00823979

A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

NCT00823979

Phase 2 Terminated 105 enrolled Pfizer
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral drugs and have NNRTI resistance mutations.

Timeline

Start
2009-03-25
Primary completion
2012-10-18
Completion
2012-10-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Etravirine Small molecule 200 mg
Subject Lersivirine Small molecule 750 mg
Subject Lersivirine Small molecule 1000 mg

Indications

No indication recorded.