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

Stopped early · Phase 2

Conditions studied: HIV-1

In brief

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.

Key facts

Study ID

NCT00823979

Run by

Pfizer

People needed

105

Starts

2009-03-25

Expected to finish

2012-10-18

Last updated by the study team

2018-12-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Office of Anthony Mills, MD, Inc. — Los Angeles, California, United States
• CARES — Sacramento, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• San Francisco Veterans Affairs Medical Center — San Francisco, California, United States
• The Kinder Medical Group — Miami, Florida, United States
• Care Resource — Miami, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Infectious Diseases Associates of Northwest Florida, PA — Pensacola, Florida, United States
• Hillsborough County Health Department — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Ruth M. Rothstein CORE Center — Chicago, Illinois, United States
• Nassau University Medical Center — East Meadow, New York, United States
• Greiger Clinic — Mount Vernon, New York, United States
• Rosedale Infectious Diseases — Huntersville, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Saint Hope Foundation - Bellaire Clinic — Bellaire, Texas, United States
• Saint Hope Foundation - Conroe Clinic — Conroe, Texas, United States
• Nicholaos C. Bellos, MD, PA — Dallas, Texas, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Saint Hope Foundation - Stafford Clinic — Stafford, Texas, United States
• Instituto A.Z. de Pesquisa e Ensino — Curitiba, Paraná, Brazil
• Hospital Geral de Nova Iguacu — Nova Iguaçu, Rio de Janeiro, Brazil
• Hospital Nossa Senhora da Conceicao — Porto Alegre, Rio Grande do Sul, Brazil
• Instituto de Infectologia Campinas — Campinas, São Paulo, Brazil
• Jeffrey Goodman Special Care Clinic — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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