Status:
TERMINATED
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
Lead Sponsor:
Pfizer
Conditions:
HIV-1
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2012
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00823979
Start Date
March 25 2009
End Date
October 18 2012
Last Update
December 4 2018
Active Locations (63)
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1
Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States, 90028
2
Office of Anthony Mills, MD, Inc.
Los Angeles, California, United States, 90069
3
CARES
Sacramento, California, United States, 95814
4
University of California Davis Medical Center
Sacramento, California, United States, 95817