|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|
|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.|
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
- Drug: UK-453,061 Dose 1
UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir.
- Drug: UK-453,061 Dose 2
UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir.
- Drug: Etravirine
Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.
- Experimental: UK- 453,061 Dose One
Intervention: Drug: UK-453,061 Dose 1
- Experimental: UK- 453,061 Dose Two
Intervention: Drug: UK-453,061 Dose 2
- Active Comparator: Comparator
Intervention: Drug: Etravirine
|October 18, 2012|
|October 18, 2012 (Final data collection date for primary outcome measure)|
- 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.
- 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
|Sexes Eligible for Study:||All|
|18 Years to 65 Years (Adult, Older Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Brazil, Germany, Italy, Malaysia, Poland, Portugal, Puerto Rico, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States|
|Argentina, Canada, France|
2007-004392-19 ( EudraCT Number )
|Study Director:||Pfizer CT.gov Call Center||Pfizer|