Conditions: HIV-1
Keywords: HIV-1 NNRTI Treatment Experienced may have Protease inhibitor experience
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 105
Healthy volunteers: no

Brief 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.

Detailed description:
The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: UK-453,061 Dose 1 intervention 2: UK-453,061 Dose 2 intervention 3: Etravirine
Intervention descriptions: intervention 1: UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir. intervention 2: UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir. intervention 3: Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.

Protocol document: