Status:
COMPLETED
A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1
Lead Sponsor:
Pfizer
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not b...
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 1,000 copies/mL
- Negative urine pregnancy test.
Exclusion
- Suspected or documented active, untreated HIV-1 related opportunist 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.
- Absolute CD4 count \<200 cells/mm3.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00824421
Start Date
February 1 2009
End Date
October 1 2011
Last Update
January 24 2014
Active Locations (31)
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1
Pfizer Investigational Site
Buenos Aires, Argentina, C1405BCH
2
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
3
Pfizer Investigational Site
Melbourne, Victoria, Australia, 3004
4
Pfizer Investigational Site
Toronto, Ontario, Canada, M5B 1L6