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

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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
22
sites
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Atlanta, Georgia 30308
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Bellaire, TX
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Chicago, Illinois 60612
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Conroe, TX
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Curitiba,
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Dallas, Texas 75204
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East Meadow, New York 11554
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Huntersville, North Carolina 28078
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Los Angeles, California 90028
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Los Angeles, California 90069
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Miami, Florida 33133
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Miami, Florida 33137
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Mount Vernon, New York 10550
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Sacramento, California 95814
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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San Francisco, California 94121
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Stafford, TX
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