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

Status:	Terminated
Conditions:	HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 65
Updated:	12/6/2018
Start Date:	March 25, 2009
End Date:	October 18, 2012

A Phase 2b Multicenter, Randomized, Comparative Trial Of Uk-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleotide/Nucleoside Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced Hiv-1 Infected Subjects With Evidence Of Nnrti Resistant Hiv-1

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.

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.

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

We found this trial at

sites

University of Cincinnati Medical Center

234 Goodman Dr
Cincinnati, Ohio 45229

(513) 584-1000