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

• Status: Terminated
• Trial end date: 2012-10-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Darunavir; Etravirine; Reverse Transcriptase Inhibitors; Ritonavir

Criteria

Inclusion Criteria:

• Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.

• HIV 1 RNA viral load of greater then 500 copies/mL.

• Negative urine pregnancy test.

Exclusion Criteria:

• Suspected or documented active, untreated HIV-1 related opportunistic infection or other condition requiring acute therapy at the time of randomization.

• Subjects with acute Hepatitis B and/or C within 30 days of randomization.

• Previous use of Darunavir or etravirine